Bleeding, Hemostasis
Conditions
Brief summary
The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.
Detailed description
This study is a prospective, non-inferiority, multi-center, randomized, open-label trial to compare HemoStyp with Surgicel® in the management of bleeding during surgery.
Interventions
DEVICEHemoStyp
During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
DEVICESurgicel
During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
Sponsors
United Health Products, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery); 2. At time of surgery has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical; 3. Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and 4. Subjects or parent or legal guardian of the subject who are willing and able to sign consent.
Exclusion criteria
1. Physical or psychological condition which would impair study participation; 2. Indications for emergency surgery; 3. Pre-operative laboratory findings of a hematologic disorder; 4. Subjects with history of moderate to severe allergies; 5. Subjects undergoing minimally invasive laparoscopic surgery; 6. Subjects who will require platelet or fresh frozen plasma transfusion during surgery; 7. Subjects who are pregnant or breast-feeding at the time of surgery; or 8. Subjects on P2Y12 platelet inhibitor (Plavix) less than 5 days prior to surgery, warfarin or Xa inhibitors not withheld per standard protocols for the management of anticoagulants pre-operatively.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period. | 10 minutes | The time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was the latter time point. The time to hemostasis was the time from start of study treatment to that last effective hemostatic time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes | Between 2 minutes and 10 minutes | Percentage of subjects achieving hemostasis at the target bleeding site at 2 minutes, 5 minutes and 10 minutes following the start of study treatment. |
| Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site | Intraoperative period | Percentage of subjects with intraoperative hemostasis at the target bleeding site during the intraoperative period. The intraoperative period started when the first cut was made to the patient and ended when the operative field was closed and dressed. |
| Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site | Intraoperative period post hemostasis | Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis |
| Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site | 30 days | Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HemoStyp Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use. | 118 |
| Surgicel Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use. | 118 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Surgicel | Total | HemoStyp |
|---|---|---|---|
| Age, Continuous | 61.48 years STANDARD_DEVIATION 16.48 | 60.19 years STANDARD_DEVIATION 16.32 | 58.89 years STANDARD_DEVIATION 16.13 |
| Diastolic Blood Pressure | 67.48 mmHg STANDARD_DEVIATION 16.09 | 67.45 mmHg STANDARD_DEVIATION 16.87 | 67.34 mmHg STANDARD_DEVIATION 16.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 57 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants | 179 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Heart Rate | 71.89 Beats Per minute STANDARD_DEVIATION 13.12 | 71.54 Beats Per minute STANDARD_DEVIATION 13.67 | 71.26 Beats Per minute STANDARD_DEVIATION 13.87 |
| Height | 168.55 cm STANDARD_DEVIATION 15.5 | 166.69 cm STANDARD_DEVIATION 19.59 | 164.84 cm STANDARD_DEVIATION 19.59 |
| Hematocrit | 36.16 percentage STANDARD_DEVIATION 7.71 | 38.15 percentage STANDARD_DEVIATION 26.52 | 40.18 percentage STANDARD_DEVIATION 26.52 |
| Hemoglobin | 12.14 grams per deciliter STANDARD_DEVIATION 2.69 | 12.25 grams per deciliter STANDARD_DEVIATION 2.83 | 12.37 grams per deciliter STANDARD_DEVIATION 2.83 |
| Lewis Bleeding Scale Grade Lewis Bleeding Scale Grade 1 | 73 Participants | 134 Participants | 61 Participants |
| Lewis Bleeding Scale Grade Lewis Bleeding Scale Grade 2 | 45 Participants | 102 Participants | 57 Participants |
| Platelet Count | 221.81 platelets per micro liter of blood STANDARD_DEVIATION 99.45 | 217.36 platelets per micro liter of blood STANDARD_DEVIATION 92.5 | 212.83 platelets per micro liter of blood STANDARD_DEVIATION 92.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 16 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 50 Participants | 28 Participants |
| Race (NIH/OMB) White | 86 Participants | 160 Participants | 74 Participants |
| Sex: Female, Male Female | 45 Participants | 97 Participants | 52 Participants |
| Sex: Female, Male Male | 73 Participants | 139 Participants | 66 Participants |
| Systolic Blood Pressure | 124.53 mmHg STANDARD_DEVIATION 26.75 | 124.26 mmHg STANDARD_DEVIATION 26.36 | 124.11 mmHg STANDARD_DEVIATION 25.14 |
| Type of Surgery Abdominal Surgery | 37 Participants | 72 Participants | 35 Participants |
| Type of Surgery Thoracic Surgery | 38 Participants | 70 Participants | 32 Participants |
| Type of Surgery Vascular Surgery | 43 Participants | 94 Participants | 51 Participants |
| Weight | 86.48 kg STANDARD_DEVIATION 49.88 | 83.24 kg STANDARD_DEVIATION 38.62 | 79.94 kg STANDARD_DEVIATION 38.62 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 118 | 1 / 118 |
| other Total, other adverse events | 0 / 118 | 4 / 118 |
| serious Total, serious adverse events | 1 / 118 | 0 / 118 |
Outcome results
Primary
The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period.
The time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was the latter time point. The time to hemostasis was the time from start of study treatment to that last effective hemostatic time point.
Time frame: 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HemoStyp | The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period. | 36 seconds |
| Surgicel | The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period. | 67 seconds |
Secondary
Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes
Percentage of subjects achieving hemostasis at the target bleeding site at 2 minutes, 5 minutes and 10 minutes following the start of study treatment.
Time frame: Between 2 minutes and 10 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HemoStyp | Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes | 2 minutes | 118 Participants |
| HemoStyp | Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes | 5 minutes | 118 Participants |
| HemoStyp | Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes | 10 minutes | 118 Participants |
| Surgicel | Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes | 2 minutes | 96 Participants |
| Surgicel | Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes | 5 minutes | 110 Participants |
| Surgicel | Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes | 10 minutes | 112 Participants |
Secondary
Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site
Percentage of subjects with intraoperative hemostasis at the target bleeding site during the intraoperative period. The intraoperative period started when the first cut was made to the patient and ended when the operative field was closed and dressed.
Time frame: Intraoperative period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoStyp | Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site | 118 Participants |
| Surgicel | Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site | 112 Participants |
Secondary
Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site
Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery.
Time frame: 30 days
Population: 3 subjects in the HemoStyp cohort and 6 subjects in the Surgicel cohort did not finish the 30 day follow up so they were not included in the analysis population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoStyp | Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site | 0 Participants |
| Surgicel | Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site | 0 Participants |
Secondary
Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site
Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis
Time frame: Intraoperative period post hemostasis
Population: 6 subjects in the Surgicel cohort could not be analyzed because hemostasis was never obtained at the target bleeding site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoStyp | Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site | 0 Participants |
| Surgicel | Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site | 0 Participants |