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Completed

NCT Number: NCT05711524

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • 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

Treatment and study plan

Traditional Cryoprecipitate

Biological

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

Pathogen-Reduced Cryoprecipitate

Biological

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

Primary outcomes

  1. Total Number of RBCs Used Over Admission

    Time frame: Within the first 30 days after surgery.

    RBCs used over admission

  2. Total Number of Platelets Used Over Admission

    Time frame: Within the first 30 days after surgery.

    Plts used over admission

  3. Total Number of Plasma Used Over Admission

    Time frame: Within the first 30 days after surgery.

    All units over admission

Secondary outcomes

  1. Number of Cryo Units Used Perioperatively

    Time frame: 3 days post procedure

    All products within 3 days

  2. Number of RBCs Used Perioperatively

    Time frame: 3 days post procedure

    Number of RBC units transfused during perioperative period

  3. Number of Plasma Used Perioperatively

    Time frame: 3 days post procedure

  4. Number of Platelets Used Perioperatively

    Time frame: 3 days post procedure

    Number of platelet units transfused during perioperative period

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

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

  6. Time From Cryo Order to Start of Transfusion

    Time frame: procedure (Time from cryo order to start of transfusion)

    Time to cryo order time to start of cryo transfusion

  7. Number of Cryo Units Wasted by Blood Bank

    Time frame: Daily, up to approximately 24 months

    This captures the Cryoprecipitate units discarded.

  8. Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation

    Time frame: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.

    FIBTEM before transfusion, if anesthesiologist orders it. FIBTEM is a point of care laboratory test measuring fibrinogen contribution to a clot. It is part of ROTEM testing and helps providers determine if patients need fibrinogen supplementation during surgical bleeding.

  9. Post Transfusion FIBTEM Amplitude at 10 Min After Start of Clot Formation

    Time frame: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.

    FIBTEM after transfusion, if anesthesiologist orders it. FIBTEM is a point of care laboratory test measuring fibrinogen contribution to a clot. It is part of ROTEM testing and helps providers determine if patients need fibrinogen supplementation during surgical bleeding.

  10. Maximum Clot Firmness (MCF)

    Time frame: Variable, but it is generally available within 1 hour of the start of ROTEM testing.

    The maximum strength of a clot as determined by ROTEM testing.

  11. Pre-transfusion Fibrinogen Level

    Time frame: During surgery, within 3 hours of specimen receipt by laboratory.

    The fibrinogen measurement before cryoprecipitate is transfused.

  12. Highest Fibrinogen Level Within 24 Hours

    Time frame: Within 24 hours after surgery

  13. Lowest Fibrinogen Level Within 24 Hours

    Time frame: Within 24 hours after surgery

  14. Cumulative Volume in Drains After Surgery (e.g., Chest Tube for CV Surgery) at the Time of Removal

    Time frame: Up to approximately 3 days

    The cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of drain removal

  15. Volume in Drains (Chest Tube for CV Surgery)

    Time frame: At 24 hours after surgery

  16. Time From End of Bypass Pump for CV Surgery

    Time frame: Until end of surgery

  17. Length of Stay in OR

    Time frame: Duration of time in operating room

    Operating room length of stay

  18. Length of Stay in ICU

    Time frame: During hospitalization, approximately 5 days to 30 days

    Participant length of stay in ICU setting

  19. Length of Stay in Hospital

    Time frame: During hospitalization, approximately 5 days to 30 days

    Overall length of stay in hospital

  20. Need for Ventilator

    Time frame: During hospitalization, approximately 5 days to 30 days

  21. Time on Ventilator

    Time frame: During hospitalization, approximately 5 days to 30 days

    If participant was on ventilator, amount of time spent on ventilator

  22. Overall Cost of Cryo vs PR Cryo, When Factoring Wastage

    Time frame: Daily, approximately 24 months

    Cost of traditional cryoprecipitate compared to PR Cryoprecipitate.

  23. Number of Participants That Experienced an Adverse Event of Fever

    Time frame: Within 5 days of surgery start time

    All participants that experience fevers that occur during the time frame

  24. Number of Participants That Experienced an Adverse Event of Infection

    Time frame: Within 5 days of surgery start time

    All participants that experience infections that occur during the time frame

  25. Number of Participants That Experienced an Adverse Event of Transfusion Reaction.

    Time frame: Within 5 days of surgery start time

    All participants that experience transfusion reactions that occur during the time frame

  26. Fibrinogen Level

    Time frame: Most proximal to end of procedure

    Fibrinogen level most proximal to the end of surgery

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Cerus Corporation

Registry information

Official study title

Pilot Clinical Trial of Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen (INTERCEPT Fibrinogen Complex) in Patients With Bleeding to Expedite Product Availability and Improve Outcomes in Perioperative Bleeding

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 3, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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