Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.
Interventions
BIOLOGICALFS VH S/D 500 s-apr, 60-seconds polymerization time
FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.
BIOLOGICALFS VH S/D 500 s-apr, 120-seconds polymerization time
Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.
Treatment of the study suture line with manual compression with surgical gauze pads.
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female of all ages * Subject undergoing peripheral vascular surgery, ie, conduit placement with an ePTFE graft such as arterio-arterial bypasses \[including: axillo-femoral, ilio-femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass\], or arteriovenous dialysis access shunt in the upper or lower extremity. * Signed informed consent Intraoperative inclusion criterion: \- Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing). Suture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.) Note: Bleedings that can be treated with additional sutures are not appropriate for the study. Such anastomoses should receive additional sutures, be re-categorized, and if they still comply with the inclusion criteria, be randomized.
Exclusion criteria
* Subjects concurrently participating in another clinical study treatment with another investigational drug or device within the last 30 days * Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed) * Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral, axillo-bifemoral etc.) * Pregnant or lactating women * Congenital coagulation disorders * Prior kidney transplantation * Heparin-induced thrombocytopenia * Known prior exposure to aprotinin within the last 12 months * Known hypersensitivity to aprotinin or other components of the product * Known severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs) * Prior radiation therapy to the operating field * Severe local inflammation at the operating field. Intraoperative exclusion criterion: * Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure. * Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | 4 minutes post start of treatment application | Hemostasis at the study suture line must be maintained. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period. |
| 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line | 4 minutes post start of treatment application | Hemostasis at the study suture line must be maintained until closure of the surgical wound. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period. |
| Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding | 4 minutes post start of treatment application | Investigators were shown videos of bleeding severities to standardize assessments. 1. Moderate bleeding defined as: * Either \>25% of the suture line bleeds, or * ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or * 1 pulsatile suture line bleeding was present. 2. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present. |
| Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding | 4 minutes post start of treatment application | Investigators were shown videos of bleeding severities to standardize assessments. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any Transfusion Requirement | Intraoperative (day 0) through day 30 ± 5 | Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets) |
| Percentage of Participants With Graft Occlusions | Day 0 (procedure day) through day 30 ± 5 | Determined clinically and defined as absence of blood flow through the graft. |
| Percentage of Participants With Infections at the Surgical Site | Day 0 (procedure day) through day 30 ± 5 | — |
| Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Within 14 days prior to date of surgery | — |
| Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Preoperative baseline through postoperative Day 14 | Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 |
| Vital Signs: Heart Rate - Preoperative Baseline | Within 14 days prior to date of surgery | — |
| Percent Change in Vital Signs: Heart Rate | Preoperative baseline through postoperative Day 14 | Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 |
| Vital Signs: Respiratory Rate - Preoperative Baseline | Within 14 days prior to date of surgery | — |
| Percent Change in Vital Signs: Respiratory Rate | Preoperative baseline through postoperative Day 14 | Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 |
| Percentage of Participants Achieving Hemostasis at 6 Minutes | 6 minutes post start of treatment application start | Hemostasis at the study suture line must be maintained until closure of the surgical wound. |
| Laboratory Values Over Time: Hematocrit | Preoperative baseline through postoperative Day 14 | — |
| Laboratory Values Over Time: Erythrocytes | Preoperative baseline through postoperative Day 14 | — |
| Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Preoperative baseline through postoperative Day 14 | — |
| Laboratory Values Over Time: Platelets | Preoperative baseline through postoperative Day 14 | — |
| Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Preoperative baseline through postoperative Day 14 | — |
| Laboratory Values Over Time: Alanine Aminotransferase (ALT) | Preoperative baseline through postoperative Day 14 | — |
| Laboratory Values Over Time: Aspartate Aminotransferase (AST) | Preoperative baseline through postoperative Day 14 | — |
| Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) | Preoperative baseline through postoperative Day 14 | — |
| Laboratory Values Over Time: International Normalized Ratio (INR) | Preoperative baseline through postoperative Day 14 | — |
| Laboratory Values Over Time: Hemoglobin | Preoperative baseline through postoperative Day 14 | — |
| Percentage of Participants Achieving Hemostasis at 10 Minutes | 10 minutes post start of treatment application | Hemostasis at the study suture line must be maintained until closure of the surgical wound. |
| Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line | Intraoperative day 0 | Intraoperative rebleeding at the study suture line after occurrence of hemostasis. |
| Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line | Postoperative through day 30 ± 5 | Any rebleeding requiring surgical reexploration |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 12 clinical sites in the United States, beginning December 2007. The last participant completed the study in December 2008
Pre-assignment details
101 participants were enrolled and screened. 26 were screen failures; 1 was excluded due to study issue; and 1 was withdrawn by investigator. Therefore, 73 of the 101 enrolled were randomized and treated.
Participants by arm
| Arm | Count |
|---|---|
| FS VH S/D 500 S-apr - 60 Seconds FS VH S/D 500 s-apr, 60 - seconds polymerization time | 26 |
| FS VH S/D 500 S-apr - 120 Seconds FS VH S/D 500 s-apr, 120 - seconds polymerization time | 24 |
| Control Group Manual compression with surgical gauze pads. | 23 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | FS VH S/D 500 S-apr - 60 Seconds | FS VH S/D 500 S-apr - 120 Seconds | Control Group | Total |
|---|---|---|---|---|
| Age Continuous | 63.0 years FULL_RANGE 12.7 | 67.0 years FULL_RANGE 14.6 | 63.0 years FULL_RANGE 14.4 | 63 years |
| Region of Enrollment United States | 26 participants | 24 participants | 23 participants | 73 participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 12 Participants | 29 Participants |
| Sex: Female, Male Male | 21 Participants | 12 Participants | 11 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 26 | 9 / 24 | 13 / 50 | 7 / 23 |
| serious Total, serious adverse events | 4 / 26 | 4 / 24 | 8 / 50 | 4 / 23 |
Outcome results
Primary
90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line
Hemostasis at the study suture line must be maintained until closure of the surgical wound. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period.
Time frame: 4 minutes post start of treatment application
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line | 46.2 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line | 62.5 percentage of participants |
| Control Group | 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line | 34.8 percentage of participants |
p-value: 0.1564Likelihood ratio chi-square test
Primary
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding
Investigators were shown videos of bleeding severities to standardize assessments. 1. Moderate bleeding defined as: * Either \>25% of the suture line bleeds, or * ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or * 1 pulsatile suture line bleeding was present. 2. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present.
Time frame: 4 minutes post start of treatment application
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding | 50.0 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding | 66.7 percentage of participants |
| Control Group | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding | 38.5 percentage of participants |
Primary
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding
Investigators were shown videos of bleeding severities to standardize assessments. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present.
Time frame: 4 minutes post start of treatment application
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding | 41.7 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding | 58.3 percentage of participants |
| Control Group | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding | 30.0 percentage of participants |
Primary
Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.
Hemostasis at the study suture line must be maintained. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period.
Time frame: 4 minutes post start of treatment application
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Additional Treatment Required for Hemostasis | 30.8 percentage of participants |
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Primary Hemostasis Achieved at 4 Minutes | 46.2 percentage of participants |
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Intraoperative Rebleeding After Primary Hemostasis | 3.8 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Additional Treatment Required for Hemostasis | 25.0 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Primary Hemostasis Achieved at 4 Minutes | 62.5 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Intraoperative Rebleeding After Primary Hemostasis | 0.0 percentage of participants |
| Control Group | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Primary Hemostasis Achieved at 4 Minutes | 34.8 percentage of participants |
| Control Group | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Intraoperative Rebleeding After Primary Hemostasis | 4.3 percentage of participants |
| Control Group | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Additional Treatment Required for Hemostasis | 52.2 percentage of participants |
Secondary
Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) | 25.10 seconds |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) | 26.30 seconds |
| Control Group | Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) | 25.90 seconds |
| Control Group | Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) | 25.10 seconds |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) | 24.65 seconds |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) | 27.20 seconds |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) | 25.00 seconds |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) | 26.75 seconds |
Secondary
Laboratory Values Over Time: Alanine Aminotransferase (ALT)
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Alanine Aminotransferase (ALT) | 16.00 U/L |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Alanine Aminotransferase (ALT) | 17.00 U/L |
| Control Group | Laboratory Values Over Time: Alanine Aminotransferase (ALT) | 16.00 U/L |
| Control Group | Laboratory Values Over Time: Alanine Aminotransferase (ALT) | 16.50 U/L |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Alanine Aminotransferase (ALT) | 12.00 U/L |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Alanine Aminotransferase (ALT) | 15.00 U/L |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Alanine Aminotransferase (ALT) | 14.00 U/L |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Alanine Aminotransferase (ALT) | 12.00 U/L |
Secondary
Laboratory Values Over Time: Aspartate Aminotransferase (AST)
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Aspartate Aminotransferase (AST) | 18.00 U/L |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Aspartate Aminotransferase (AST) | 19.00 U/L |
| Control Group | Laboratory Values Over Time: Aspartate Aminotransferase (AST) | 18.00 U/L |
| Control Group | Laboratory Values Over Time: Aspartate Aminotransferase (AST) | 16.00 U/L |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Aspartate Aminotransferase (AST) | 18.00 U/L |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Aspartate Aminotransferase (AST) | 20.00 U/L |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Aspartate Aminotransferase (AST) | 19.00 U/L |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Aspartate Aminotransferase (AST) | 17.50 U/L |
Secondary
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Creatinine | 4.20 mg/dL |
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | BUN | 24.00 mg/dL |
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Bilirubin | 0.40 mg/dL |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | BUN | 31.00 mg/dL |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Bilirubin | 0.30 mg/dL |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Creatinine | 1.90 mg/dL |
| Control Group | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | BUN | 26.00 mg/dL |
| Control Group | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Creatinine | 3.50 mg/dL |
| Control Group | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Bilirubin | 0.30 mg/dL |
| Control Group | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Creatinine | 2.65 mg/dL |
| Control Group | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Bilirubin | 0.40 mg/dL |
| Control Group | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | BUN | 29.00 mg/dL |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Bilirubin | 0.30 mg/dL |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Creatinine | 4.60 mg/dL |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | BUN | 30.00 mg/dL |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Bilirubin | 0.40 mg/dL |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Creatinine | 2.40 mg/dL |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | BUN | 26.00 mg/dL |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Bilirubin | 0.30 mg/dL |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Creatinine | 3.50 mg/dL |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | BUN | 27.00 mg/dL |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Creatinine | 3.25 mg/dL |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | Bilirubin | 0.30 mg/dL |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) | BUN | 27.00 mg/dL |
Secondary
Laboratory Values Over Time: Erythrocytes
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Erythrocytes | 4.10 x10^6/µl |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Erythrocytes | 4.15 x10^6/µl |
| Control Group | Laboratory Values Over Time: Erythrocytes | 4.10 x10^6/µl |
| Control Group | Laboratory Values Over Time: Erythrocytes | 4.40 x10^6/µl |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Erythrocytes | 3.75 x10^6/µl |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Erythrocytes | 4.15 x10^6/µl |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Erythrocytes | 3.90 x10^6/µl |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Erythrocytes | 4.00 x10^6/µl |
Secondary
Laboratory Values Over Time: Hematocrit
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Hematocrit | 37.00 percentage of red blood cells in blood |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Hematocrit | 37.00 percentage of red blood cells in blood |
| Control Group | Laboratory Values Over Time: Hematocrit | 37.00 percentage of red blood cells in blood |
| Control Group | Laboratory Values Over Time: Hematocrit | 39.00 percentage of red blood cells in blood |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Hematocrit | 35.00 percentage of red blood cells in blood |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Hematocrit | 38.00 percentage of red blood cells in blood |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Hematocrit | 37.00 percentage of red blood cells in blood |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Hematocrit | 36.50 percentage of red blood cells in blood |
Secondary
Laboratory Values Over Time: Hemoglobin
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Hemoglobin | 12.00 g/dl |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Hemoglobin | 12.55 g/dl |
| Control Group | Laboratory Values Over Time: Hemoglobin | 12.25 g/dl |
| Control Group | Laboratory Values Over Time: Hemoglobin | 12.15 g/dl |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Hemoglobin | 11.15 g/dl |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Hemoglobin | 12.40 g/dl |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Hemoglobin | 12.05 g/dl |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Hemoglobin | 11.70 g/dl |
Secondary
Laboratory Values Over Time: International Normalized Ratio (INR)
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: International Normalized Ratio (INR) | 1.00 ratio |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: International Normalized Ratio (INR) | 1.10 ratio |
| Control Group | Laboratory Values Over Time: International Normalized Ratio (INR) | 1.00 ratio |
| Control Group | Laboratory Values Over Time: International Normalized Ratio (INR) | 1.05 ratio |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: International Normalized Ratio (INR) | 1.00 ratio |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: International Normalized Ratio (INR) | 1.00 ratio |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: International Normalized Ratio (INR) | 1.00 ratio |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: International Normalized Ratio (INR) | 1.00 ratio |
Secondary
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Basophils | 0.05 x10^3/µl |
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Neutrophils | 3.70 x10^3/µl |
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Leukocytes | 6.31 x10^3/µl |
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Eosinophils | 0.17 x10^3/µl |
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Lymphocytes | 1.50 x10^3/µl |
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Monocytes | 0.34 x10^3/µl |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Leukocytes | 7.14 x10^3/µl |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Neutrophils | 4.69 x10^3/µl |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Lymphocytes | 1.74 x10^3/µl |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Basophils | 0.05 x10^3/µl |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Monocytes | 0.41 x10^3/µl |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Eosinophils | 0.14 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Monocytes | 0.36 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Basophils | 0.05 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Leukocytes | 6.62 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Eosinophils | 0.15 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Neutrophils | 4.11 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Lymphocytes | 1.55 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Neutrophils | 5.24 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Basophils | 0.04 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Leukocytes | 7.98 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Eosinophils | 0.19 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Lymphocytes | 1.59 x10^3/µl |
| Control Group | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Monocytes | 0.39 x10^3/µl |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Neutrophils | 4.44 x10^3/µl |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Basophils | 0.04 x10^3/µl |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Monocytes | 0.35 x10^3/µl |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Leukocytes | 6.58 x10^3/µl |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Lymphocytes | 1.50 x10^3/µl |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Eosinophils | 0.21 x10^3/µl |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Eosinophils | 0.24 x10^3/µl |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Lymphocytes | 1.46 x10^3/µl |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Basophils | 0.05 x10^3/µl |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Neutrophils | 5.23 x10^3/µl |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Leukocytes | 7.87 x10^3/µl |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Monocytes | 0.43 x10^3/µl |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Lymphocytes | 1.48 x10^3/µl |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Neutrophils | 4.66 x10^3/µl |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Leukocytes | 7.00 x10^3/µl |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Eosinophils | 0.23 x10^3/µl |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Monocytes | 0.38 x10^3/µl |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Basophils | 0.05 x10^3/µl |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Lymphocytes | 1.94 x10^3/µl |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Eosinophils | 0.21 x10^3/µl |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Monocytes | 0.44 x10^3/µl |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Neutrophils | 5.54 x10^3/µl |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Leukocytes | 8.13 x10^3/µl |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes | Basophils | 0.04 x10^3/µl |
Secondary
Laboratory Values Over Time: Platelets
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Laboratory Values Over Time: Platelets | 184.00 x10^3/µl |
| FS VH S/D 500 S-apr - 120-Seconds | Laboratory Values Over Time: Platelets | 204.00 x10^3/µl |
| Control Group | Laboratory Values Over Time: Platelets | 195.50 x10^3/µl |
| Control Group | Laboratory Values Over Time: Platelets | 233.00 x10^3/µl |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Platelets | 226.00 x10^3/µl |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Platelets | 333.00 x10^3/µl |
| FS All: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Platelets | 275.00 x10^3/µl |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Laboratory Values Over Time: Platelets | 295.00 x10^3/µl |
Secondary
Percentage of Participants Achieving Hemostasis at 10 Minutes
Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Time frame: 10 minutes post start of treatment application
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants Achieving Hemostasis at 10 Minutes | 65.4 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants Achieving Hemostasis at 10 Minutes | 75.0 percentage of participants |
| Control Group | Percentage of Participants Achieving Hemostasis at 10 Minutes | 43.5 percentage of participants |
p-value: 0.123Likelihood ratio chi-square test
p-value: 0.026Likelihood ratio chi-square test
Secondary
Percentage of Participants Achieving Hemostasis at 6 Minutes
Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Time frame: 6 minutes post start of treatment application start
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants Achieving Hemostasis at 6 Minutes | 61.5 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants Achieving Hemostasis at 6 Minutes | 75.0 percentage of participants |
| Control Group | Percentage of Participants Achieving Hemostasis at 6 Minutes | 34.8 percentage of participants |
p-value: 0.06Likelihood ratio chi-square test
p-value: 0.005Likelihood ratio chi-square test
Secondary
Percentage of Participants With Any Transfusion Requirement
Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)
Time frame: Intraoperative (day 0) through day 30 ± 5
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants With Any Transfusion Requirement | 3.8 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants With Any Transfusion Requirement | 12.5 percentage of participants |
| Control Group | Percentage of Participants With Any Transfusion Requirement | 13.0 percentage of participants |
p-value: 0.234Likelihood ratio chi-square test
p-value: 0.955Likelihood ratio chi-square test
Secondary
Percentage of Participants With Graft Occlusions
Determined clinically and defined as absence of blood flow through the graft.
Time frame: Day 0 (procedure day) through day 30 ± 5
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants With Graft Occlusions | 7.7 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants With Graft Occlusions | 4.2 percentage of participants |
| Control Group | Percentage of Participants With Graft Occlusions | 6.0 percentage of participants |
| Control Group | Percentage of Participants With Graft Occlusions | 0.0 percentage of participants |
p-value: 0.106Likelihood ratio chi-square test
p-value: 0.243Likelihood ratio chi-square test
p-value: 0.127Likelihood ratio chi-square test
Secondary
Percentage of Participants With Infections at the Surgical Site
Time frame: Day 0 (procedure day) through day 30 ± 5
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants With Infections at the Surgical Site | 3.8 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants With Infections at the Surgical Site | 8.3 percentage of participants |
| Control Group | Percentage of Participants With Infections at the Surgical Site | 6.0 percentage of participants |
| Control Group | Percentage of Participants With Infections at the Surgical Site | 0.0 percentage of participants |
p-value: 0.257Likelihood ratio chi-square test
p-value: 0.096Likelihood ratio chi-square test
p-value: 0.127Likelihood ratio chi-square test
Secondary
Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line
Intraoperative rebleeding at the study suture line after occurrence of hemostasis.
Time frame: Intraoperative day 0
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line | 3.8 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line | 0.0 percentage of participants |
| Control Group | Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line | 4.3 percentage of participants |
p-value: 0.929Likelihood ratio chi-square test
p-value: 0.228Likelihood ratio chi-square test
Secondary
Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line
Any rebleeding requiring surgical reexploration
Time frame: Postoperative through day 30 ± 5
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line | 0.0 percentage of participants |
| FS VH S/D 500 S-apr - 120-Seconds | Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line | 0.0 percentage of participants |
| Control Group | Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line | 0.0 percentage of participants |
Secondary
Percent Change in Vital Signs: Heart Rate
Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percent Change in Vital Signs: Heart Rate | -7.0 percent change |
| FS VH S/D 500 S-apr - 120-Seconds | Percent Change in Vital Signs: Heart Rate | -2.6 percent change |
| Control Group | Percent Change in Vital Signs: Heart Rate | -6.3 percent change |
| Control Group | Percent Change in Vital Signs: Heart Rate | -9.5 percent change |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Heart Rate | -6.7 percent change |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Heart Rate | 2.0 percent change |
| FS All: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Heart Rate | -1.4 percent change |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Heart Rate | 9.9 percent change |
| FS 60: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Heart Rate | 3.0 percent change |
| FS 120: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Heart Rate | 7.4 percent change |
| FS All: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Heart Rate | 4.4 percent change |
| Control Group: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Heart Rate | 1.8 percent change |
Secondary
Percent Change in Vital Signs: Respiratory Rate
Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percent Change in Vital Signs: Respiratory Rate | 0.0 percent change |
| FS VH S/D 500 S-apr - 120-Seconds | Percent Change in Vital Signs: Respiratory Rate | -10.0 percent change |
| Control Group | Percent Change in Vital Signs: Respiratory Rate | -10.0 percent change |
| Control Group | Percent Change in Vital Signs: Respiratory Rate | 0.0 percent change |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Respiratory Rate | 0.0 percent change |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Respiratory Rate | 0.0 percent change |
| FS All: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Respiratory Rate | 0.0 percent change |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Respiratory Rate | 0.0 percent change |
Secondary
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure
Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Time frame: Preoperative baseline through postoperative Day 14
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -10.1 percent change |
| FS VH S/D 500 S-apr- 60-Seconds | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -8.2 percent change |
| FS VH S/D 500 S-apr - 120-Seconds | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -6.5 percent change |
| FS VH S/D 500 S-apr - 120-Seconds | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -16.4 percent change |
| Control Group | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -9.8 percent change |
| Control Group | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -11.4 percent change |
| Control Group | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -17.2 percent change |
| Control Group | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -21.9 percent change |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -1.5 percent change |
| FS 60: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -6.4 percent change |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -12.4 percent change |
| FS 120: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -19.4 percent change |
| FS All: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -7.5 percent change |
| FS All: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -7.9 percent change |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -11.0 percent change |
| Control Group: Preoperative Baseline - Postoperative Day 1 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -9.6 percent change |
| FS 60: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -3.8 percent change |
| FS 60: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | 0.0 percent change |
| FS 120: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -3.7 percent change |
| FS 120: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -7.5 percent change |
| FS All: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -1.1 percent change |
| FS All: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -3.8 percent change |
| Control Group: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -7.1 percent change |
| Control Group: Preoperative Baseline - Postoperative Day 14 | Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure | Systolic blood pressure | -6.6 percent change |
Secondary
Vital Signs: Heart Rate - Preoperative Baseline
Time frame: Within 14 days prior to date of surgery
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Vital Signs: Heart Rate - Preoperative Baseline | 72.0 Heart beats/ minute |
| FS VH S/D 500 S-apr - 120-Seconds | Vital Signs: Heart Rate - Preoperative Baseline | 71.5 Heart beats/ minute |
| Control Group | Vital Signs: Heart Rate - Preoperative Baseline | 72.0 Heart beats/ minute |
| Control Group | Vital Signs: Heart Rate - Preoperative Baseline | 74.0 Heart beats/ minute |
Secondary
Vital Signs: Respiratory Rate - Preoperative Baseline
Time frame: Within 14 days prior to date of surgery
Population: Safety Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Vital Signs: Respiratory Rate - Preoperative Baseline | 18.0 Breaths/ minute |
| FS VH S/D 500 S-apr - 120-Seconds | Vital Signs: Respiratory Rate - Preoperative Baseline | 20.0 Breaths/ minute |
| Control Group | Vital Signs: Respiratory Rate - Preoperative Baseline | 18.0 Breaths/ minute |
| Control Group | Vital Signs: Respiratory Rate - Preoperative Baseline | 18.0 Breaths/ minute |
Secondary
Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline
Time frame: Within 14 days prior to date of surgery
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FS VH S/D 500 S-apr- 60-Seconds | Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Systolic blood pressure | 137.5 mm Hg |
| FS VH S/D 500 S-apr- 60-Seconds | Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Diastolic blood pressure | 71.0 mm Hg |
| FS VH S/D 500 S-apr - 120-Seconds | Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Diastolic blood pressure | 73.5 mm Hg |
| FS VH S/D 500 S-apr - 120-Seconds | Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Systolic blood pressure | 142.5 mm Hg |
| Control Group | Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Diastolic blood pressure | 72.0 mm Hg |
| Control Group | Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Systolic blood pressure | 141.5 mm Hg |
| Control Group | Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Diastolic blood pressure | 78.0 mm Hg |
| Control Group | Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline | Systolic blood pressure | 150.0 mm Hg |