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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654560
• Other study ID #: UHP001
• Status: Completed
• Phase: N/A
• Start date: December 28, 2018
• Est. completion date: September 12, 2019

Study information

• Verified date: October 2019
• Source: United Health Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: September 12, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Hemostasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Raymond Schaerf	Burbank	California

Sponsors (1)

Lead Sponsor	Collaborator
United Health Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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