Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding

NCT05711524 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 22-04024649
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypofibrinogenemia; Bleeding

Keywords

Cryoprecipitate; Pathogen Reduced Cryoprecipitate

Outcome Measures

Primary Outcomes (3)

• Total Number of RBCs Used Over Admission

  RBCs used over admission

  Within the first 30 days after surgery.

• Total Number of Platelets Used Over Admission

  Plts used over admission

  Within the first 30 days after surgery.

• Total Number of Plasma Used Over Admission

  All units over admission

  Within the first 30 days after surgery.

Secondary Outcomes (26)

• Number of Cryo Units Used Perioperatively

  3 days post procedure

• Number of RBCs Used Perioperatively

  3 days post procedure

• Number of Plasma Used Perioperatively

  3 days post procedure

• Number of Platelets Used Perioperatively

  3 days post procedure

• Time From Operating Room (OR) Start Time to Start of Cryo Transfusion

  procedure (Time from OR start time to start of cryo transfusion)

Study Arms (2)

Patients given Traditional Cryo

ACTIVE COMPARATOR

These are the liver transplant and cardiothoracic (LT and CT) patients that will be given traditional cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.

Biological: Traditional Cryoprecipitate

Patients given PR Cryo

EXPERIMENTAL

These are the liver transplant and cardiothoracic (LT and CT) patients that will be given PR cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.

Biological: Pathogen-Reduced Cryoprecipitate

Interventions

Traditional Cryoprecipitate BIOLOGICAL

This is the cryoprecipitate already currently being given to patients with a cryo order.

Patients given Traditional Cryo

Pathogen-Reduced Cryoprecipitate BIOLOGICAL

This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.

Patients given PR Cryo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnant women

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Cerus Corporation: collaborator

Study Sites (1)

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Related Publications (10)

• Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE. Appropriate statistical methods were infrequently used in cluster-randomized crossover trials. J Clin Epidemiol. 2016 Jun;74:40-50. doi: 10.1016/j.jclinepi.2015.11.013. Epub 2015 Nov 26.

  PMID: 26633599 BACKGROUND

• Saland LC. Effects of reserpine administration on the fine structure of the rat pars intermedia. Cell Tissue Res. 1978 Nov 9;194(1):115-23. doi: 10.1007/BF00209237.

  PMID: 719724 BACKGROUND

• Cushing MM, Fitzgerald MM, Harris RM, Asmis LM, Haas T. Influence of cryoprecipitate, Factor XIII, and fibrinogen concentrate on hyperfibrinolysis. Transfusion. 2017 Oct;57(10):2502-2510. doi: 10.1111/trf.14259. Epub 2017 Jul 21.

  PMID: 28734018 BACKGROUND

• Cushing MM, Haas T, Karkouti K, Callum J. Which is the preferred blood product for fibrinogen replacement in the bleeding patient with acquired hypofibrinogenemia-cryoprecipitate or fibrinogen concentrate? Transfusion. 2020 Jun;60 Suppl 3:S17-S23. doi: 10.1111/trf.15614. Epub 2020 Jun 1.

  PMID: 32478877 BACKGROUND

• Fenderson JL, Meledeo MA, Rendo MJ, Peltier GC, McIntosh CS, Davis KW, Corley JB, Cap AP. Hemostatic characteristics of thawed, pooled cryoprecipitate stored for 35 days at refrigerated and room temperatures. Transfusion. 2019 Apr;59(S2):1560-1567. doi: 10.1111/trf.15180.

  PMID: 30980741 BACKGROUND

• Bulkley GB, Wheaton LG, Strandberg JD, Zuidema GD. Assessment of small intestinal recovery from ischemic injury after segmental, arterial, venous, and arteriovenous occlusion. Surg Forum. 1979;30:210-3. No abstract available.

  PMID: 538597 BACKGROUND

• Hsien S, Dayton JD, Chen D, Stock A, Bacha E, Cushing MM, Nellis ME. Hemostatic efficacy of pathogen-reduced platelets in children undergoing cardiopulmonary bypass. Transfusion. 2022 Feb;62(2):298-305. doi: 10.1111/trf.16768. Epub 2021 Dec 13.

  PMID: 34904250 BACKGROUND

• Lokhandwala PM, O'Neal A, Patel EU, Brunker PAR, Gehrie EA, Zheng G, Kickler TS, Ness PM, Tobian AAR. Hemostatic profile and safety of pooled cryoprecipitate up to 120 hours after thawing. Transfusion. 2018 May;58(5):1126-1131. doi: 10.1111/trf.14550. Epub 2018 Feb 25.

  PMID: 29479708 BACKGROUND

• Thomson C, Sobieraj-Teague M, Scott D, Duncan E, Abraham S, Roxby D. Extending the post-thaw viability of cryoprecipitate. Transfusion. 2021 May;61(5):1578-1585. doi: 10.1111/trf.16366. Epub 2021 Mar 17.

  PMID: 33728705 BACKGROUND

• Cushing MM, Cohen T, Fitzgerald MM, Rand S, Sinfort A, Chen D, Keltner N, Ong S, Parra P, Benabdessadek D, Jimenez A, Haas T, Lau C, Girardi NI, DeSimone RA. Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study protocol for a single center, prospective, cluster randomized trial. Trials. 2024 Sep 27;25(1):625. doi: 10.1186/s13063-024-08398-x.

  PMID: 39334317 DERIVED

MeSH Terms

Conditions

Afibrinogenemia; Hemorrhage

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Melissa Cushing
• Organization: Weill Cornell Medicine

mec2013@med.cornell.edu

212-746-3527

Study Officials

• Melissa Cushing

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention and randomization are not made at the level of the individual patient, but rather on clusters of patients by month. The clusters will include all patients at NYP/WC for whom pooled cryo is ordered during a single month.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: April 1, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 3, 2025
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)