Clinical trial NCT02502019: HEMOBLAST Pilot Clinical Investigation
Official title: Prospective, Multicenter, Single-arm Pilot Clinical Investigation Evaluating the Use of a Surface Bleeding Severity Scale (SBSS) and the Safety and Efficacy of a New Hemostatic Device in Abdominal and Orthopedic Lower Extremity Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemostasis
Lead sponsor: Biom'Up France SAS
Sponsor class: INDUSTRY
First posted: 2015-07-17
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.

This is a prospective, multicenter, single-arm pilot clinical investigation. There will be 36 subjects enrolled across 4 investigational sites.

The subjects will be followed at hospital charge and 6 weeks postoperatively.

The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.

Secondary endpoints of this clinical investigation consist of:

* Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application;
* Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application;
* Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application; and
* Incidence of adverse events through final follow-up.

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 \< 100,000 per microliter and/or International Normalized Ratio \> 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.

Primary outcomes:
measure: Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators
timeFrame: Intraoperative
Secondary outcomes:
measure: Hemostatic Within 6 Minutes
timeFrame: Intraoperative
measure: Hemostasis Within 10 Minutes
timeFrame: Intraoperative
measure: Hemostasis Within 3 Minutes
timeFrame: Intraoperative
measure: Adverse Events
timeFrame: 6 +/- 2 weeks after implant
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Danville
country: United States
facility: Danville Orthopedic Clinic
state: Virginia
Study officials:
affiliation: University of Southern California
name: Linda Sher, MD
role: PRINCIPAL_INVESTIGATOR
References: