Phase 1
N=27
HEMOBLAST Pilot Clinical Investigation
Hemostasis
Bottom Line
View on ClinicalTrials.gov: NCT02502019 ↗Enrolled (actual)
27
Serious AEs
14.8%
Results posted
Feb 2019
Primary outcome: Primary: Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators — 0.7754 Kappa statistic
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- HEMOBLAST Bellows (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Biom'Up France SAS
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators |
0.7754 | — |
| SECONDARY Hemostatic Within 6 Minutes |
19 | — |
| SECONDARY Hemostasis Within 10 Minutes |
22 | — |
| SECONDARY Hemostasis Within 3 Minutes |
12 | — |
| SECONDARY Adverse Events |
15 | — |
Summary
The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.
Eligibility Criteria
Inclusion Criteria
- • Subject is undergoing an elective open abdominal or orthopedic lower extremity surgery;
- Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;
- Subjects on antiplatelets, including aspirin, will discontinue medication at least 10 days prior to surgery; and
- Subject is 21 years of age or older.
- 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 achieving hemostasis are ineffective or impractical; and
- Subject has a TBS with an SBSS score of 1, 2, or 3.
Exclusion Criteria
- • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;
- Subject is undergoing a spinal surgical procedure;
- Subject is undergoing a neurologic surgical procedure;
- Subject is undergoing an emergency surgical procedure;
- Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
- Subject has a clinically significant coagulation disorder or disease, defined as a platelet count 1.5 within 4 weeks of surgery;
- Subject had chronic corticosteroid use within 2 weeks prior to surgery;
- Subject receiving intravenous heparin or oral Coumadin within 24 hours of surgery;
- Subject has an active or suspected infection at the surgical site;
- Subject has had or has planned any organ transplantation;
- 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 ASA classification of > 4;
- Subject has a life expectancy of less than 3 months;
- Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;
- Subject has a documented severe congenital or acquired immunodeficiency;
- Subject has religious or other objections to porcine or bovine components;
- Subject in whom the investigational device will be used at the site of a cemented or uncemented porous coated joint implant;
- Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and
- Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator.
Data sourced from ClinicalTrials.gov (NCT02502019). 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.