Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting

Conditions
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Hemostasis, Bleeding

Intervention / Treatment
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* Device: HemoStyp
* Device: Surgicel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery); 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; Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and Subjects or parent or legal guardian of the subject who are willing and able to sign consent. Exclusion Criteria: Physical or psychological condition which would impair study participation; Indications for emergency surgery; Pre-operative laboratory findings of a hematologic disorder; Subjects with history of moderate to severe allergies; Subjects undergoing minimally invasive laparoscopic surgery; Subjects who will require platelet or fresh frozen plasma transfusion during surgery; Subjects who are pregnant or breast-feeding at the time of surgery; or 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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HemoStyp<br>Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use. | Device: HemoStyp<br>* 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.<br>|
| Active Comparator: Surgicel<br>Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use. | Device: Surgicel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Between 2 minutes and 10 minutes | 
| 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. | Intraoperative period | 
| 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 | Intraoperative period post hemostasis | 
| 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. | 30 days |