FS VH S/D 500 S-apr in Vascular Surgery

Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00892957

Enrollment

176

Registered

2009-05-05

Start date

2009-07-31

Completion date

2010-11-30

Last updated

2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses

Keywords

Vascular Surgery, Arterio-arterial bypasses, Arterio-venous (AV) shunts

Brief summary

The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.

Interventions

BIOLOGICALFibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)

The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).

OTHERSurgical gauze pads

Manual compression with surgical gauze pads

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Preoperative inclusion criteria: * Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including: * axillo-femoral * axillo-bifemoral * aorto-bifemoral * ilio-femoral * femoro-femoral * ilio-popliteal * femoro-popliteal (including below knee) * femoro-tibial vessel bypass * arterio-venous shunting for dialysis access in the upper or lower extremity * Signed informed consent * Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study. * Subject is willing and able to comply with the requirements of the protocol. Intraoperative inclusion criterion: * Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.)

Exclusion criteria

Preoperative

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.	4 minutes post start of treatment application	Hemostasis at the study suture line must be maintained until closure of the surgical wound.
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. 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.
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 Postoperative Rebleeding	Postoperative through day 30 ± 5	Any rebleeding requiring surgical re-exploration
Percentage of Participants With Graft Occlusion	post-op discharge/day 1, post-op day 14 and day 30	Determined clinically and defined as absence of blood flow through the graft.
Percentage of Participants With Infection at the Surgical Site	post-op discharge/day 1, post-op day 14 and day 30	—
Vital Signs: Heart Rate - Preoperative Baseline	Within 14 days prior to date of surgery	—
Number of Participants With Infections by Grade	post-op discharge/day 1, post-op day 14 and day 30	Infections were recorded according to: * Grade I: only dermis affected * Grade II: infection invades subcutaneous region but not the arterial implant * Grade III: the arterial implant is infected
Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline	Within 14 days prior to date of surgery	—
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure	Within 14 days prior to surgery 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
Percent Change in Vital Signs: Heart Rate	Within 14 days prior to surgery 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	Within 14 days prior to surgery through postoperative day 14	Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application	6 minutes post start of treatment application	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 Who Achieved Hemostasis at 10 Minutes Post Treatment Application	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 Study Suture Line	Intraoperative day 0	Intraoperative rebleeding at the study suture line after occurrence of hemostasis.

Countries

United States

Participant flow

Recruitment details

Patients were enrolled at 24 clinical sites in the United States, beginning July 2009 and completing in October 2010

Pre-assignment details

176 participants were enrolled. 32 were screen failures. 1 was withdrawn by investigator (study coordinator not available to collect data), 2 participants requested withdrawal, 1 participant died prior to screening and prior to receiving study treatment. Therefore, 140 of the 176 enrolled were randomized.

Participants by arm

Arm	Count
FS VH S/D 500 S-apr FS VH S/D 500 s-apr will be applied to the study suture line.	70
Control - Manual Compression With Surgical Gauze Pads Dry gauze pads will be positioned to cover the complete study suture line.	70
Total	140

Withdrawals & dropouts

Period	Reason	FG000	FG001
Between Postoperative Day 1 and Day 14	Death	0	2
Between Postoperative Day 1 and Day 14	Lost to Follow-up	0	2

Baseline characteristics

Characteristic	FS VH S/D 500 S-apr	Control - Manual Compression With Surgical Gauze Pads	Total
Age Continuous	62.5 years STANDARD_DEVIATION 12.6	66.3 years STANDARD_DEVIATION 11.5	64.4 years STANDARD_DEVIATION 12.2
Region of Enrollment United States	70 participants	70 participants	140 participants
Sex: Female, Male Female	40 Participants	33 Participants	73 Participants
Sex: Female, Male Male	30 Participants	37 Participants	67 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	14 / 70	7 / 70
serious Total, serious adverse events	20 / 70	18 / 70

Outcome results

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. 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.

Time frame: 4 minutes post start of treatment application

Population: Intent to Treat

Arm	Measure	Value (NUMBER)
FS VH S/D 500 S-apr: Baseline	Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding	75.9 percentage of participants
FS VH S/D 500 S-apr: Postoperative Day 14	Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding	48.1 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: Baseline	Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding	53.7 percentage of participants
FS VH S/D 500 S-apr: Postoperative Day 14	Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding	20.9 percentage of participants

Primary

Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Time frame: 4 minutes post start of treatment application

Population: Intent to Treat

Arm	Measure	Value (NUMBER)
FS VH S/D 500 S-apr: Baseline	Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.	62.9 Percentage of participants
FS VH S/D 500 S-apr: Postoperative Day 14	Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.	31.4 Percentage of participants

p-value: <0.0001Likelihood ratio chi-square test

Secondary