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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03654560
Other study ID # UHP001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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