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Hemostatic Agent
GATT-Patch vs TachoSil for Liver Surgery-related Bleeding
N/A
Recruiting
Led By Hans de Wilt
Research Sponsored by GATT Technologies BV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is 22 years of age or older at the time of enrollment
Subject in whom the Investigator is able to identify a target bleeding site at the liver resection plane for which any applicable conventional means for hemostasis (e.g. suture, ligature or cautery) are ineffective or impractical, and the choice is made to use a hemostatic agent to stop the bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is comparing the safety and performance of two products for managing bleeding during elective open liver surgery.
Who is the study for?
This trial is for adults aged 22 or older who are scheduled for elective open liver surgery and need a hemostatic agent due to ineffective conventional bleeding control methods. Excluded are those with severe blood clotting issues, high bilirubin levels, pregnancy, hypersensitivity to certain animal proteins or dyes, infections at the bleeding site, imminent organ transplants, participation in other trials within 30 days affecting this study's endpoints.Check my eligibility
What is being tested?
The trial compares GATT-Patch against TachoSil for safety and effectiveness in managing minimal to moderate bleeding during liver surgery. It's pre-market research involving random assignment of participants (2:1 ratio) across multiple centers internationally.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to components like porcine gelatin or horse proteins found in the patches and complications related to improper bleeding management at the surgical site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
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My doctor identified a bleeding site in my liver that can't be stopped with usual methods.
Select...
I am scheduled for elective open liver surgery.
Select...
My bleeding severity is minimal to moderate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of hemostasis at 3 minutes without rebleeding at the 10-minute time point
Secondary outcome measures
Kaplan-Meier estimated distribution of time to hemostasis
Mean time to hemostasis (seconds)
Rate of subjects with hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 seconds
+2 moreOther outcome measures
Amount of hemostatic material needed versus bleeding surface
Aspect of postoperative drainage
Cancer-free survival
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GATT-PatchExperimental Treatment1 Intervention
Hemostatic patch
Group II: TachoSilActive Control1 Intervention
Hemostatic patch
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GATT-Patch
2021
N/A
~50
Find a Location
Who is running the clinical trial?
Syneos HealthOTHER
172 Previous Clinical Trials
68,324 Total Patients Enrolled
GATT Technologies BVLead Sponsor
2 Previous Clinical Trials
97 Total Patients Enrolled
1 Trials studying Intraoperative Blood Loss
50 Patients Enrolled for Intraoperative Blood Loss
Hans de WiltPrincipal InvestigatorRadboud University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery for a large artery or vein injury to keep it open.I object to medical products from animals or humans due to my religious beliefs.I am scheduled for a specific liver surgery to remove part of my liver.I am 22 years old or older.My doctor identified a bleeding site in my liver that can't be stopped with usual methods.I am scheduled for surgery on an organ other than the liver.I am undergoing surgery to donate part of my liver.I am scheduled for elective open liver surgery.I am on blood thinners but may only be taking aspirin now.I have or might have an infection where I'm bleeding.The investigational device will be used where I have a synthetic graft or patch.My bleeding severity is minimal to moderate.I have had or am planning to have an organ transplant.I haven't been in another study that could affect this one in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: GATT-Patch
- Group 2: TachoSil
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.
How many participants are currently registered for this medical experiment?
"Affirmative. Clinicaltrials.gov provides proof that this clinical trial, which was initially advertised on the 4th of August 2022, is currently in recruitment mode. The research team requires 130 participants to be admitted from two separate medical centres."
Answered by AI
Is there availability in this clinical trial for potential participants?
"As indicated by the clinicaltrials.gov listing, this medical trial has been open for recruitment since August 4th 2022 and was recently updated on August 5th 2022."
Answered by AI
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