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HEMOBLAST Pivotal Clinical Investigation

B

Biom'Up

Status

Completed

Conditions

Hemostasis

Treatments

Device: HEMOBLAST Bellows
Device: Absorbable gelatin sponge, USP with thrombin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02780869
ETC 2015-002

Details and patient eligibility

About

The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.

Enrollment

258 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • • Subject is undergoing an elective open cardiothoracic, 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;
    • Subject undergoing cardiothoracic surgery is not allergic to protamine; and
    • Subject is 21 years of age or older.

Exclusion criteria

  • • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;

    • Subject is undergoing a neurologic surgical procedure;
    • Subject is undergoing a spinal 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 < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery;
    • Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery;
    • Subject receiving antiplatelet medications within 5 days prior to surgery;
    • Subject undergoing abdominal or orthopedic lower extremity surgery receiving aspirin within 7 days prior to surgery;
    • Subject has an active or suspected infection at the surgical site;
    • Subject has had or has planned to receive 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 5;
    • 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, bovine, or human components;
    • Subject in whom the investigational or control device will be used at the site of a valve replacement or repair;
    • Subject in whom the investigational or control device will be used at the site of a synthetic graft or patch 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.

Intraoperative Eligibility Criteria:

  • Subject does not have an active or suspected infection at the surgical site;
  • Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment;
  • Subject in whom the Investigator is able to identify a TBS for which any applicable conventional means for hemostasis are ineffective or impractical; and
  • Subject has a TBS with an SBSS score of 1, 2, or 3.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

258 participants in 2 patient groups

Investigational
Experimental group
Description:
HEMOBLAST Bellows
Treatment:
Device: HEMOBLAST Bellows
Control
Active Comparator group
Description:
Absorbable gelatin sponge, USP with thrombin
Treatment:
Device: Absorbable gelatin sponge, USP with thrombin

Trial documents
2

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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