Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT04058223 - Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Completed NCT04590898 - Peri-device Leakage Closure After LAAO
Active, not recruiting NCT05563883 - Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
Not yet recruiting NCT04537533 - Tranexamic Acid Infusion in Low Dose Versus in High Dose for Reducing Blood Loss in Radical Cystectomy Operations Phase 4
Withdrawn NCT02851940 - Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids N/A
Completed NCT02722720 - Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral N/A
Recruiting NCT02279186 - Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section Phase 4
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT02245854 - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps N/A
Completed NCT02092415 - Assessment of Limb Perfusion During Junctional Tourniquet N/A
Completed NCT02980497 - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study N/A
Not yet recruiting NCT01438736 - Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern? Phase 4
Completed NCT00515541 - Lovaza's Effect on the Activation of Platelets Phase 2
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Terminated NCT03954314 - DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery Phase 3
Recruiting NCT05945680 - Tranexamic Acid in Breast Esthetic Surgery. Phase 4
Recruiting NCT03783182 - Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy Phase 4
Not yet recruiting NCT05464394 - Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass Phase 3