Cardiothoracic SurgeryNCT03725098
Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
A study testing HEMOBLAST Bellows and FLOSEAL in people with Cardiothoracic Surgery, run by Biom'Up France SAS at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiothoracic Surgery
- What is being tested?
- HEMOBLAST Bellows and FLOSEAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2019to 28 Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Houston Methodist
Houston, Texas, 77030
University of California Los Angeles
Los Angeles, California, 90095
Ochsner Clinic Foundation
New Orleans, Louisiana, 70124
About this study
Official title: Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.
Read the detailed description
A maximum of 104 subjects will be enrolled across a maximum of 5 study sites in the United States.
The estimated duration of the study is approximately 8 months from the time of first subject enrollment to the last subject enrollment. Enrollment occurs intraoperatively after confirmation of the intraoperative eligibility criteria. Subjects will undergo intraoperative performance assessments and then will be discontinued from the study after completion of the intraoperative visit.
- Conditions
- Cardiothoracic Surgery
- Being tested
- HEMOBLAST Bellows, FLOSEAL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMOBLAST BellowsDevice
The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
FLOSEALDevice
The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
| Study group | Role | What they receive |
|---|---|---|
| HEMOBLAST Bellows (Hemostatic Device) | Experimental | Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use Receives: Device: HEMOBLAST Bellows |
| FLOSEAL (Hemostatic Device) | Active comparator | Bleeding sites will be treated with FLOSEAL per its approved Indications for Use Receives: Device: FLOSEAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes
The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.
Measured: Intraoperative
Secondary outcomes (1)
5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes
The secondary endpoint of this study is non-inferiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 5 minutes.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Mar 2019
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiothoracic SurgeryStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biom'Up France SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Bruckner, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725098
- Sponsor's protocol ID
- ETC 2018-005
- Status last verified
- Jan 2020
- First submitted
- 8 Oct 2018
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dang NC, Ardehali A, Bruckner BA, Parrino PE, Gillen DL, Hoffman RW, Spotnitz R, Cavoores S, Shorn IJ, Manson RJ, Spotnitz WD. Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations. J Card Surg. 2020 Feb;35(2):313-319. doi: 10.1111/jocs.14376. Epub 2019 Nov 25.
PubMed 31763732
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
- ClinicalTrials.gov ID
- NCT03725098
- Acronym / sponsor ID
- ETC 2018-005
- Conditions
- Cardiothoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Biom'Up France SASIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.
Detailed description
A maximum of 104 subjects will be enrolled across a maximum of 5 study sites in the United States.
The estimated duration of the study is approximately 8 months from the time of first subject enrollment to the last subject enrollment. Enrollment occurs intraoperatively after confirmation of the intraoperative eligibility criteria. Subjects will undergo intraoperative performance assessments and then will be discontinued from the study after completion of the intraoperative visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEMOBLAST Bellows (Hemostatic Device) | Experimental | Device: HEMOBLAST BellowsBleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use |
| FLOSEAL (Hemostatic Device) | Active comparator | Device: FLOSEALBleeding sites will be treated with FLOSEAL per its approved Indications for Use |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 BellowsThe HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures. | Device | HEMOBLAST Bellows (Hemostatic Device) |
| FLOSEALThe FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. | Device | FLOSEAL (Hemostatic Device) |
Primary outcome
3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes
Time frame: Intraoperative
The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.
1 secondary outcome
5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31763732Dang NC, Ardehali A, Bruckner BA, Parrino PE, Gillen DL, Hoffman RW, Spotnitz R, Cavoores S, Shorn IJ, Manson RJ, Spotnitz WD. Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations. J Card Surg. 2020 Feb;35(2):313-319. doi: 10.1111/jocs.14376. Epub 2019 Nov 25.
- Individual participant dataSharing planned: No
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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.
Brian Bruckner, MD principal investigator
The Methodist Hospital Research Institute
4 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 FLOSEAL in people with Cardiothoracic Surgery, run by Biom'Up France SAS at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 13 Jan 2020). 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?
3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes (time frame: Intraoperative). 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 NCT03725098, which also lists 1 linked publication.
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 13 Jan 2020.