HemostasisNCT02780869

HEMOBLAST Pivotal Clinical Investigation

A study testing HEMOBLAST Bellows and Absorbable gelatin sponge, USP with thrombin in people with Hemostasis, run by Biom'Up France SAS at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Hemostasis
What is being tested?: HEMOBLAST Bellows and Absorbable gelatin sponge, USP with thrombin
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 258 participants
Where: 17 sitesUnited States
Study dates: 18 Jul 2016to 27 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

• 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.

Who cannot join

• 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;

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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 locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Suburban Hospital - Johns Hopkins Medicine
Bethesda, Maryland, 20814
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
University of Virginia
Charlottesville, Virginia
Spectrum Medical
Danville, Virginia
Duke University
Durham, North Carolina
Dartmouth Hitchcock Medical Center
Hanover, New Hampshire
Queens Medical Center
Honolulu, Hawaii
Hunstad Kortesis Center
Huntsville, North Carolina
University of California Los Angeles
Los Angeles, California
University of Southern California
Los Angeles, California
Miami Plastic Surgery
Miami, Florida
Intermountain Liver Disease and Transplant Center
Murray, Utah
Columbia University Medical Center / New York Presbyterian Hospital
New York, New York
Icahn School of Medicine at Mount Sinai
New York, New York
Lotus Clinical Research
Pasadena, California
CORE Institute
Phoenix, Arizona
Washington University in St. Louis
St Louis, Missouri

Other trials in United States

About this study

Official title: Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries

Conditions: Hemostasis
Being tested: HEMOBLAST Bellows, Absorbable gelatin sponge, USP with thrombin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HEMOBLAST BellowsDevice
Absorbable gelatin sponge, USP with thrombinDevice

Study groups in NCT02780869
Study group	Role	What they receive
Investigational	Experimental	HEMOBLAST Bellows Receives: Device: HEMOBLAST Bellows
Control	Active comparator	Absorbable gelatin sponge, USP with thrombin Receives: Device: Absorbable gelatin sponge, USP with thrombin

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Subjects Achieving Hemostasis
The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.
Measured: Intraoperative, 6 Minutes Post-Application

Secondary outcomes (2)

Product Preparation Time
The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.
Measured: Intraoperative
Proportion of Subjects Achieving Hemostasis
The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated
Measured: Intraoperative, 3 Minutes Post-Application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 201627 Mar 2017

First posted24 May 2016 (estimated)
Study start18 Jul 2016
Primary completion1 Feb 2017
Study completion27 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HemostasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02780869
Sponsor's protocol ID: ETC 2015-002
Status last verified: Dec 2018
First submitted: 19 May 2016
Last updated: 27 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hemostasis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries
ClinicalTrials.gov ID: NCT02780869
Acronym / sponsor ID: ETC 2015-002
Conditions: Hemostasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: Biom'Up France SASIndustry (pharma, biotech, devices)
Study start: 18 Jul 2016 (actual)
Primary completion: 1 Feb 2017 (actual)
Study completion: 27 Mar 2017 (actual)
First posted: 24 May 2016 (estimated)
Results: Posted 7 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Investigational	Experimental	Device: HEMOBLAST BellowsHEMOBLAST Bellows
Control	Active comparator	Device: Absorbable gelatin sponge, USP with thrombinAbsorbable gelatin sponge, USP with thrombin

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

• Subject is undergoing an elective open cardiothoracic, abdominal, or orthopedic lower extremity surgery;

Key exclusion criteria (26 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HEMOBLAST Bellows	Device	Investigational
Absorbable gelatin sponge, USP with thrombin	Device	Control

Primary outcome

Proportion of Subjects Achieving Hemostasis
Time frame: Intraoperative, 6 Minutes Post-Application
The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.

2 secondary outcomes

Product Preparation Time
Time frame: Intraoperative
Proportion of Subjects Achieving Hemostasis
Time frame: Intraoperative, 3 Minutes Post-Application

Results and safety

Results posted to the registry on 7 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational	175	162
Control	83	74

Primary outcome: Proportion of Subjects Achieving Hemostasis

Time frame: Intraoperative, 6 Minutes Post-Application. Count of participants. Unit: Participants

Measure	Investigational n = 159	Control n = 83
Value	148	61

Investigational vs Control: p <0.0001, Cochran-Mantel-Haenszel
Investigational vs Control: p = 0.0001, Cochran-Mantel-Haenszel

Population analysed: The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enrollment until completion of 6-week follow-up visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational	19 of 175 (10.9%)	84 of 175 (48%)	0 of 175
Control	11 of 83 (13.3%)	47 of 83 (56.6%)	3 of 83

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hemostasis

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Chapman, MD principal investigator

Washington University School of Medicine

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HEMOBLAST Bellows and Absorbable gelatin sponge, USP with thrombin in people with Hemostasis, run by Biom'Up France SAS at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects Achieving Hemostasis (time frame: Intraoperative, 6 Minutes Post-Application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02780869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.