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

NCT03654560 | Completed Results FDA Device

• 1 other identifier: UHP001
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemostasis; Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes

  Between 2 minutes and 10 minutes

• Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site

  Intraoperative period

• Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site

  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

  30 days

Study Arms (2)

HemoStyp

ACTIVE COMPARATOR

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

Device: HemoStyp

Surgicel

ACTIVE COMPARATOR

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

Device: Surgicel

Interventions

HemoStyp 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.

HemoStyp

Surgicel 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.

Surgicel

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Health Products, Inc.: lead

Study Sites (1)

Raymond Schaerf

Burbank, California, 91505, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gerard Abate, MD Chief Medical Officer
• Organization: United Health Products, Inc.

G.Abate@unitedhealthproductsinc.com

(386) 627-1598

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 31, 2018
• Study Start: December 28, 2018
• Primary Completion: August 5, 2019
• Study Completion: September 12, 2019
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2019-10

Locations

US (1)