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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding; Hemostasis
• Intervention / Treatment: Device: HemoStyp; Device: Surgicel

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.

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Burbank, California, United States, 91505
      • Raymond Schaerf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: HemoStyp; Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.	Device: 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.
ACTIVE_COMPARATOR: Surgicel; Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: United Health Products, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 28, 2018
• Primary Completion (ACTUAL): August 5, 2019
• Study Completion (ACTUAL): September 12, 2019

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (ACTUAL): August 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UHP001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No