Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily used for fibrinogen replacement in the US, cryoprecipitate (cryo), must be stored frozen and expires six hours after thawing, resulting in a delay in transfusion of approximately 50 minutes from the time it is ordered, as well as unnecessary transfusion of more readily available but not indicated blood components that are transfused while the patients waits for cryo . A modified version of the product, pathogen reduced (PR) cryo, is now FDA approved and can be thawed and stored for 5 days, allowing the product to be available immediately when needed. In this quality improvement study, the investigators will compare the effect that readily available, pre-thawed PR cryo has on transfusion practice in cardiovascular and liver transplant patients who receive PR cryo versus those who receive traditional cryo by randomizing cryo transfusions in the blood bank by month to all cryo or all PR cryo. All clinical decisions, including the need for cryo, and laboratory testing will occur per standard of care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05711524
Study type Interventional
Source Weill Medical College of Cornell University
Contact Melissa Cushing
Phone 212-746-3527
Email mec2013@med.cornell.edu
Status Recruiting
Phase Phase 4
Start date April 1, 2023
Completion date March 2025

See also
  Status Clinical Trial Phase
Completed NCT04058223 - Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Completed NCT04590898 - Peri-device Leakage Closure After LAAO
Active, not recruiting NCT05563883 - Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
Not yet recruiting NCT04537533 - Tranexamic Acid Infusion in Low Dose Versus in High Dose for Reducing Blood Loss in Radical Cystectomy Operations Phase 4
Withdrawn NCT02851940 - Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids N/A
Completed NCT02722720 - Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral N/A
Recruiting NCT02279186 - Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section Phase 4
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT02092415 - Assessment of Limb Perfusion During Junctional Tourniquet N/A
Completed NCT02245854 - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps N/A
Completed NCT02980497 - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study N/A
Not yet recruiting NCT01438736 - Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern? Phase 4
Completed NCT00515541 - Lovaza's Effect on the Activation of Platelets Phase 2
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Terminated NCT03954314 - DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery Phase 3
Recruiting NCT05945680 - Tranexamic Acid in Breast Esthetic Surgery. Phase 4
Recruiting NCT03783182 - Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy Phase 4
Not yet recruiting NCT05464394 - Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass Phase 3