Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in P… (NCT05711524) | Clinical Trial Compass
CompletedPhase 4
Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
United States208 participantsStarted 2023-04-01
Plain-language summary
The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided.
Participants will be given one of the two FDA-approved blood products.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period.
. Cardiovascular surgery includes the following procedures:
. coronary artery bypass grafting
. valve repair or replacement
. open thoracic aortic and thoracoabdominal aortic surgery
. atrial or ventricular septal defects
. ventricular assist device implantation or revision
. or any combination of the above.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Number of RBCs Used Over Admission
Timeframe: Within the first 30 days after surgery.
2
Total Number of Platelets Used Over Admission
Timeframe: Within the first 30 days after surgery.
3
Total Number of Plasma Used Over Admission
Timeframe: Within the first 30 days after surgery.
Trial details
NCT IDNCT05711524
SponsorWeill Medical College of Cornell University
. Patients who do not receive any cryo product in the OR
. Patients who are not cardiovascular surgery or liver transplant patients
. Cardiac transplantation surgery
. Patients who receive a product in error within either the cryo time period or the PR cryo time period. For example, PR cryo during a cryo month or cryo during a PR cryo time month.
. Patients who receive less than 1 pool (5 units) of cryo
. Pediatric patients (less than 18 years of age).
. Patients who received both PR cryo and traditional cryo