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

United Health Products

Status: Completed

Conditions: Hemostasis; Bleeding

Treatments: Device: Surgicel; Device: HemoStyp

Study type: Interventional

Funder types: Industry

Identifiers

NCT03654560

UHP001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

HemoStyp

Active Comparator group

Description:

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

Treatment:

Device: HemoStyp

Surgicel

Active Comparator group

Description:

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

Treatment:

Device: Surgicel