N/A
N=236
Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Hemostasis · Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT03654560 ↗Enrolled (actual)
236
Serious AEs
0.4%
Results posted
Oct 2020
Primary outcome: 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. — 36; 67 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HemoStyp (Device); Surgicel (Device)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- United Health Products, Inc.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
36; 67 | — |
| SECONDARY Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes |
118; 96; 118; 110; 118; 112 | — |
| SECONDARY Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site |
118; 112 | — |
| SECONDARY Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site |
0; 0 | — |
| SECONDARY Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03654560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.