CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 236 enrolled
Drug / intervention
HemoStyp +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03654560
NCT03654560N/ACompleted
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Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting

United Health Products, Inc.·interventional·Posted Aug 31, 2018·Updated Oct 22, 2020

In Brief

A clinical study evaluating HemoStyp and Surgicel for Hemostasis and Bleeding. Completed, enrolled 236 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis, Bleeding
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 31, 2018
Enrollment StartDec 28, 2018
Primary CompletionAug 5, 2019
Study CompletionSep 12, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.8 years ago

Interventions

HemoStypdevice

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.

Surgiceldevice

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.