HemostasisNCT04728087
ACCEL Absorbable Hemostat
A study testing ACCEL® Absorbable Hemostat Powder and Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01) in people with Hemostasis, run by Hemostasis, LLC at 7 sites in United States.
Trial summary
The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the safety and efficacy of the ACCEL® Absorbable Hemostat Powder as compared to gelatin sponge, for achieving hemostasis in subjects undergoing… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hemostasis
- What is being tested?
- ACCEL® Absorbable Hemostat Powder and Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Oct 2021to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-Surgery:
- Subject is greater than or equal to 22 years old
- Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical procedure
- Subject is willing and able to provide appropriate (Institutional Review Board (IRB) approved) informed consent.
- The subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule.
- The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder
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- The subject is willing to be treated with a commercially available absorbable gelatin sponge
- During Surgery:
- Subject has not received blood transfusions between screening and application of investigational product or commercially available absorbable gelatin sponge
- There is an estimated TBS surface area of ≤ 60 cm2
- Visual observation of oozing (0.01 g/10s ˂ Flow ˂ 0.04 g/10s), mild (0.04 g/10s ≤ Flow ˂ 0.32 g/10s), or moderate (0.32 g/10s ≤ Flow ˂ 1.01 g/10s) bleeding as validated and when control by conventional surgical techniques, including but not limited to suture, ligature and cautery, is ineffective and/or impractical
- There is an absence of intra-operative complications other than bleeding, which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety
- There has been no intra-operative use of adjunct hemostat(s) on the target bleeding site identified for application of the study treatment
Who cannot join
- Pre-Surgery:
- The subject is pregnant (verified in a manner consistent with institution's standard of care)
- Subject is lactating
- Subject is currently participating in another investigational device or drug trial or has participated in one in the past 4 weeks (prior to surgery) or is planning to participate in another research study involving any investigational product within 4 weeks after surgery
- Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
- Subject has medical, social, or psychosocial issues that the Investigator believes could impact the subject's safety or compliance with study procedures
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- Subject has a known allergy to potatoes
- Subject has a known allergy to porcine collagen/gelatin
- Subject has a religious or other objection to porcine products
- Subject is unwilling to receive blood products
- Subject has history of heparin-induced thrombocytopenia (only for cardiovascular subjects where heparin use is required)
- Subject with a baseline abnormality of INR > 2.5 or an aPTT> 100 seconds during screening that is not explained by current drug treatment (e.g. heparin, warfarin, etc.).
- Subjects with platelets < 100 X 109 PLT/L during screening
- Subject with Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) > 3 X upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit normal for these analytes due to the nature of their disease
- Subject is unwilling or unable to return for the required follow-up after surgery
- During Surgery:
- Subject has an operative bleeding site which the surgeon is unable or unwilling to control with a hemostatic agent
- Extracorporeal cardiopulmonary bypass circuits or blood salvage circuits are to be used during or after identification of the TBS.
- There has been intra-operative use of thrombin on the patient.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 5 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Kristen Matlock, BSN, RN, 214-645-7739, kristen.matlock@utsouthwestern.edu
Sarah McNeil, RN, 214-645-7728, Sarah.McNeil@UTSouthwestern.edu
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Mariah Merriam, 214-645-0424, Mariah.Merriam@UTSouthwestern.edu
Molly Sperry, 214-645-0445, Molly.Sperry@UTSouthwestern.edu
- Completed
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
- Completed
Keck Medical Center of USC
Los Angeles, California, 90033
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Sydney Thompson, 608-263-2565, thompsonsy@surgery.wisc.edu
Chris Rokkas, MD
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Grant Bochicchio, MD, 314-362-9347, gbochicchio@wustl.edu
Kelly Bochicchio, 314-286-2965, kbochicchio@wustl.edu
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Kyle Stumbaugh, 314-747-0707, Kyles@wustl.edu
James Hermeyer, 314.362.3341, hermeyer.j@wustl.edu
About this study
Official title: ACCEL® Absorbable Hemostat Powder Clinical Trial
The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the safety and efficacy of the ACCEL® Absorbable Hemostat Powder as compared to gelatin sponge, for achieving hemostasis in subjects undergoing cardiovascular, liver, or soft tissue surgery, when control of oozing to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
- Conditions
- Hemostasis
- Being tested
- ACCEL® Absorbable Hemostat Powder, Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCEL® Absorbable Hemostat PowderDevice
Up to 2 bellows (10 grams nominal) of ACCEL®
Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01)Device
Also called SURGIFOAM® (Absorbable Gelatin Sponge, Manufacturer Part Number ETH1974).
Up to 12.5 cm x 8.0 cm of Gelfoam® or SURGIFOAM® .
| Study group | Role | What they receive |
|---|---|---|
| ACCEL | Experimental | Participant will be treated with up to 2 bellows (10 grams nominal) of ACCEL®. Receives: Device: ACCEL® Absorbable Hemostat Powder |
| Gelfoam or SURGIFOAM | Active comparator | Participant will be treated with up to 12.5 cm x 8.0 cm of Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01) or SURGIFOAM® (Absorbable Gelatin Sponge, Manufacturer Part Number ETH1974). Receives: Device: Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of non-inferiority
Comparison of the percentage of subjects achieving hemostasis within three (3) minutes for cardiovascular surgery and within five (5) minutes for liver surgery and soft tissue surgery of the TBS using the ACCEL® Absorbable Hemostat Powder as compared to the control hemostat.
Measured: Day 0 / Surgery
Determination of incidence of SADE and ADE
The analysis and comparison of the incidence of SADEs and ADEs through the six (6) week follow-up endpoint for the ACCEL® Absorbable Hemostat Powder and the control hemostat.
Measured: Through the six (6) week follow-up.
Secondary outcomes (3)
Determination of TTH
A comparison of TTH (either 90 seconds or 3 minutes for cardiovascular and either 2 minutes or 5 minutes for liver surgery and soft tissue surgery) for the application of ACCEL® Absorbable Hemostat Powder and the control hemostat on the TBS.
Measured: Day 0 / Surgery
Individual subject success rate
A comparison of the proportion of individual subject successes (i.e., successful hemostasis and no SADEs and ADEs) for the application of ACCEL® Absorbable Hemostat Powder and the control hemostat on the TBS.
Measured: Through the six (6) week follow-up.
Length of individual subject hospitalization
The calculation and comparison of the number of days of individual subject hospitalization through the post-surgical (Day 1-7) follow-up endpoint for the ACCEL® Absorbable Hemostat Powder and the control hemostat.
Measured: Through the post-surgical follow-up (Day 1-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start26 Oct 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemostasis, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728087
- Sponsor's protocol ID
- Protocol 0312
- Status last verified
- Nov 2023
- First submitted
- 21 Jan 2021
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCEL® Absorbable Hemostat Powder Clinical Trial
- ClinicalTrials.gov ID
- NCT04728087
- Acronym / sponsor ID
- Protocol 0312
- Conditions
- Hemostasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Hemostasis, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the safety and efficacy of the ACCEL® Absorbable Hemostat Powder as compared to gelatin sponge, for achieving hemostasis in subjects undergoing cardiovascular, liver, or soft tissue surgery, when control of oozing to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACCEL | Experimental | Device: ACCEL® Absorbable Hemostat PowderParticipant will be treated with up to 2 bellows (10 grams nominal) of ACCEL®. |
| Gelfoam or SURGIFOAM | Active comparator | Device: Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01)Participant will be treated with up to 12.5 cm x 8.0 cm of Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01) or SURGIFOAM® (Absorbable Gelatin Sponge, Manufacturer Part Number ETH1974). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is greater than or equal to 22 years old
- Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical procedure
- Subject is willing and able to provide appropriate (Institutional Review Board (IRB) approved) informed consent.
- The subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule.
- The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder
Key exclusion criteria (19 listed)
- The subject is pregnant (verified in a manner consistent with institution's standard of care)
- Subject is lactating
- Subject is currently participating in another investigational device or drug trial or has participated in one in the past 4 weeks (prior to surgery) or is planning to participate in another research study involving any investigational product within 4 weeks after surgery
- Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
- Subject has medical, social, or psychosocial issues that the Investigator believes could impact the subject's safety or compliance with study procedures
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 |
|---|---|---|
| ACCEL® Absorbable Hemostat PowderUp to 2 bellows (10 grams nominal) of ACCEL® | Device | ACCEL |
| Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01)Also: SURGIFOAM® (Absorbable Gelatin Sponge, Manufacturer Part Number ETH1974).Up to 12.5 cm x 8.0 cm of Gelfoam® or SURGIFOAM® . | Device | Gelfoam or SURGIFOAM |
Primary outcome
Demonstration of non-inferiority
Time frame: Day 0 / Surgery
Comparison of the percentage of subjects achieving hemostasis within three (3) minutes for cardiovascular surgery and within five (5) minutes for liver surgery and soft tissue surgery of the TBS using the ACCEL® Absorbable Hemostat Powder as compared to the control hemostat.
Determination of incidence of SADE and ADE
Time frame: Through the six (6) week follow-up.
The analysis and comparison of the incidence of SADEs and ADEs through the six (6) week follow-up endpoint for the ACCEL® Absorbable Hemostat Powder and the control hemostat.
3 secondary outcomes
Determination of TTH
Time frame: Day 0 / Surgery
Individual subject success rate
Time frame: Through the six (6) week follow-up.
Length of individual subject hospitalization
Time frame: Through the post-surgical follow-up (Day 1-7)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACCEL® Absorbable Hemostat Powder and Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01) in people with Hemostasis, run by Hemostasis, LLC at 7 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 13 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurelius D Butler, MS (651-621-8295, AButler@hemostasisllc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of non-inferiority (time frame: Day 0 / Surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2024.