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

NCT ID: NCT03654560

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-28
• Study Completion Date: 2019-09-12

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.

Conditions

Hemostasis; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HemoStyp

Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.

Group Type: ACTIVE_COMPARATOR

HemoStyp

Intervention Type: DEVICE

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.

Surgicel

Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.

Group Type: ACTIVE_COMPARATOR

Surgicel

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United Health Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Raymond Schaerf

Burbank, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UHP001

Identifier Type: -

Identifier Source: org_study_id