Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Completed · Not applicable
Conditions studied: Hemostasis, Bleeding
In brief
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.
Key facts
- Study ID
- NCT03654560
- Run by
- United Health Products, Inc.
- People needed
- 236
- Starts
- 2018-12-28
- Expected to finish
- 2019-09-12
- Last updated by the study team
- 2020-10-22
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Raymond Schaerf — Burbank, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.