CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
HEMOBLAST Bellows +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/NCT03725098
NCT03725098N/ACompleted
CompareCT.gov

Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations

Biom'Up France SAS·interventional·Posted Oct 30, 2018·Updated Jan 13, 2020

In Brief

A clinical study evaluating HEMOBLAST Bellows and FLOSEAL for Cardiothoracic Surgery. Completed, enrolled 105 participants across 4 sites.

Detailed Summary

The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiothoracic Surgery
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 30, 2018
Enrollment StartMar 1, 2019
Primary CompletionJun 28, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.7 years ago

Interventions

HEMOBLAST Bellowsdevice

The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.

FLOSEALdevice

The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.