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

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ClinicalTrials.gov Identifier: NCT03654560
Recruitment Status : Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
United Health Products, Inc.

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.

Condition or disease Intervention/treatment Phase
Hemostasis Bleeding Device: HemoStyp Device: Surgicel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Actual Study Start Date : December 28, 2018
Actual Primary Completion Date : August 5, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.




Primary Outcome Measures :
  1. Rate of Non-inferiority of HemoStyp versus Surgicel measured using time to hemostasis from start of study treatment at target bleeding site until 10 minutes after treatment initiation. [ Time Frame: 10 minutes ]
    Time to hemostasis from start of study treatment at target bleeding site until 10 minutes after treatment initiation. The non-inferiority of HemoStyp versus Surgicel will be evaluated. If the criteria for non-inferiority are satisfied, a superiority analysis will be performed.


Secondary Outcome Measures :
  1. Percentage of Subjects Achieving Hemostasis between 2 minutes and 10 minutes [ Time Frame: 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.

  2. Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site [ Time Frame: Intraoperative period ]
    Percentage of subjects with intraoperative hemostasis at the target bleeding site during the intraoperative period.

  3. Rate of Subjects with intraoperative re-bleeding from the target bleeding site [ Time Frame: Intraoperative period post hemostasis ]
    Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis

  4. Rate of subjects requiring surgical re-exploration up to 30 days after surgery for re-bleeding from the target bleeding site [ Time Frame: 30 days ]
    Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654560


Locations
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United States, California
Raymond Schaerf
Burbank, California, United States, 91505
Sponsors and Collaborators
United Health Products, Inc.

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Responsible Party: United Health Products, Inc.
ClinicalTrials.gov Identifier: NCT03654560     History of Changes
Other Study ID Numbers: UHP001
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Hemostatics
Coagulants