N/A
N=105
Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
Cardiothoracic Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03725098 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes — 34; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HEMOBLAST Bellows (Device); FLOSEAL (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Biom'Up France SAS
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes |
34; 5 | — |
| SECONDARY 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes |
49; 23 | — |
Summary
The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.
Eligibility Criteria
Preoperative Inclusion Criteria
- Subject is undergoing a non-emergent cardiothoracic surgery; and
- Subject or an authorized legal representative is willing and able to give prior written informed consent for study participation.
Preoperative Exclusion Criteria
- Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
- Subject has religious or other objections to porcine or bovine components; and
- Subject is not appropriate for inclusion in the clinical study, per the medical opinion of the Investigator.
Intraoperative Inclusion Criteria
- Subject does not have an active or suspected infection at the surgical site;
- Subject in whom the Investigator is able to identify a Target Bleeding Site (TBS) for which any applicable conventional means for hemostasis are ineffective or impractical; and
- Subject has a TBS with minimal, mild, or moderate bleeding
Data sourced from ClinicalTrials.gov (NCT03725098). 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.