Your session is about to expire
← Back to Search
Hemostatic Agent
ACCEL Hemostat vs Gelatin Sponge for Surgical Bleeding Control
N/A
Recruiting
Research Sponsored by Hemostasis, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical procedure
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the post-surgical follow-up (day 1-7)
Awards & highlights
Study Summary
This trial is designed to compare the safety and efficacy of the ACCEL® Absorbable Hemostat Powder to gelatin sponge for achieving hemostasis in subjects undergoing surgery, when standard surgical techniques are ineffective.
Who is the study for?
This trial is for adults over 22 years old undergoing cardiovascular, liver, or soft tissue surgery with specific levels of bleeding that's hard to control by usual methods. They must be able to consent and follow the study plan. Pregnant women, those in other trials recently, prisoners, minors, or anyone unable to consent due to mental/physical conditions are excluded.Check my eligibility
What is being tested?
The ACCEL® Absorbable Hemostat Powder is being tested against a standard gelatin sponge (Gelfoam®) for stopping bleeding during certain surgeries when traditional methods don't work well. It's a controlled trial where patients are randomly assigned one of the two treatments.See study design
What are the potential side effects?
Potential side effects may include allergic reactions if sensitive to potato-based products or porcine collagen/gelatin used in these hemostatic agents. Other risks could relate to the general use of hemostats such as failure to stop bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for heart, liver, or soft tissue surgery.
Select...
My bleeding is not controlled by standard surgical methods.
Select...
I am willing to be treated with a gelatin sponge.
Select...
I am willing to use ACCEL® Absorbable Hemostat Powder for treatment.
Select...
I am 22 years old or older.
Select...
My burn affects an area of 60 cm2 or less.
Select...
No blood clotting agents were used on my bleeding site during surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through the post-surgical follow-up (day 1-7)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the post-surgical follow-up (day 1-7)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Demonstration of non-inferiority
Determination of incidence of SADE and ADE
Secondary outcome measures
Determination of TTH
Individual subject success rate
Length of individual subject hospitalization
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ACCELExperimental Treatment1 Intervention
Participant will be treated with up to 2 bellows (10 grams nominal) of ACCEL®.
Group II: Gelfoam or SURGIFOAMActive Control1 Intervention
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).
Find a Location
Who is running the clinical trial?
Hemostasis, LLCLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for heart, liver, or soft tissue surgery.You are allergic to collagen or gelatin derived from pigs.You are allergic to potatoes.You have a religious or personal objection to using products derived from pigs.You will not be included if a special machine called a cardiopulmonary bypass or blood salvage circuit is needed during or after the study.My liver enzymes are high, but it's due to my liver surgery or cancer spread to the liver.My bleeding is not controlled by standard surgical methods.I am willing to be treated with a gelatin sponge.My surgeon cannot stop my bleeding with usual methods.I am not a prisoner, under 18, or unable to consent due to mental or physical conditions.I am willing to use ACCEL® Absorbable Hemostat Powder for treatment.My blood takes longer to clot and it's not because of my medications.I cannot commit to follow-up visits after surgery.I am 22 years old or older.Thrombin was used during my surgery.I am willing and able to follow the study's requirements and visit schedule.I am not currently in, nor have I been in the last 4 weeks, any drug or device trials, and I don't plan to join one within 4 weeks after surgery.I am unwilling to receive blood transfusions.My burn affects an area of 60 cm2 or less.I had surgery without major issues that could affect my treatment's success or safety.No blood clotting agents were used on my bleeding site during surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Gelfoam or SURGIFOAM
- Group 2: ACCEL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What key goals is this clinical trial attempting to accomplish?
"Hemostasis, LLC, the study sponsor, has outlined that this trial will evaluate non-inferiority over a 6 week period. Secondary objectives involve ascertaining individual subject success rate for ACCEL® Absorbable Hemostat Powder in comparison to the control hemostat, as well as determining time-to-hemostatis (TTH) of both interventions on TBS."
Answered by AI
What is the scope of enrollees for this experimental program?
"Affirmative. According to clinicaltrials.gov, the trial posted on October 26th 2021 is still recruiting individuals for participation. A total of 216 patients need to be enrolled in two medical centres."
Answered by AI
Is the recruiting process for this study still active?
"The clinical trial is actively looking for participants, according to the information on clinicialtrials.gov; it was initially posted on October 26th 2021 and has had its details updated as recently as April 7th 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger