Clinical trial NCT05711524: Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hypofibrinogenemia
Bleeding
Keywords: Cryoprecipitate
Pathogen Reduced Cryoprecipitate
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Cerus Corporation
First posted: 2023-02-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period.
2. Cardiovascular surgery includes the following procedures:

   1. coronary artery bypass grafting
   2. valve repair or replacement
   3. open thoracic aortic and thoracoabdominal aortic surgery
   4. atrial or ventricular septal defects
   5. ventricular assist device implantation or revision
   6. or any combination of the above.

Exclusion Criteria:

1. Patients who do not receive any cryo product in the OR
2. Patients who are not cardiovascular surgery or liver transplant patients
3. Cardiac transplantation surgery
4. 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.
5. Patients who receive less than 1 pool (5 units) of cryo
6. Pediatric patients (less than 18 years of age).
7. Patients who received both PR cryo and traditional cryo
8. Pregnant women

Primary outcomes:
measure: Total number of RBCs used over admission
timeFrame: Within the first 30 days after surgery.
measure: Total number of platelets used over admission
timeFrame: Within the first 30 days after surgery.
measure: Total number of plasma used over admission
timeFrame: Within the first 30 days after surgery.
Secondary outcomes:
measure: Number of cryo or fibrinogen concentrate products used perioperatively
timeFrame: 3 days post procedure
measure: Number of RBCs used perioperatively
timeFrame: 3 days post procedure
measure: Number of plasma used perioperatively
timeFrame: 3 days post procedure
measure: Number of platelets used perioperatively
timeFrame: 3 days post procedure
measure: Time from OR start time to start of cryo transfusion
timeFrame: procedure (Time from OR start time to start of cryo transfusion)
measure: Time from cryo order to start of transfusion
timeFrame: procedure (Time from cryo order to start of transfusion)
measure: Number of cryo units wasted by blood bank
timeFrame: Daily, up to approximately 24 months
measure: Pre transfusion FIBTEM amplitude at 10mins
timeFrame: Within 10 minutes to one hour after the end of the first cryo transfusion.
measure: Post transfusion FIBTEM amplitude at 10mins
timeFrame: Within 10 minutes to one hour after the end of the first cryo transfusion.
measure: Maximum clot firmness at 10mins
timeFrame: Within 10 minutes to one hour after the end of the first cryo transfusion.
measure: Fibrinogen level at 10mins
timeFrame: Within 10 minutes to one hour after the end of the first cryo transfusion.
measure: Highest fibrinogen level within 24 hours
timeFrame: Within 24 hours after surgery
measure: Lowest fibrinogen level within 24 hours
timeFrame: Within 24 hours after surgery
measure: Cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of removal
timeFrame: Up to approximately 3 days
measure: Volume in drains (e.g. chest tube for CV surgery)
timeFrame: At 24 hours after surgery
measure: Time from end of bypass pump for CV surgery
timeFrame: Until end of surgery
measure: Length of stay in OR
timeFrame: During hospitalization, approximately 5 days to 30 days
measure: Length of stay in ICU
timeFrame: During hospitalization, approximately 5 days to 30 days
measure: Length of stay in hospital
timeFrame: During hospitalization, approximately 5 days to 30 days
measure: Need for ventilator
timeFrame: During hospitalization, approximately 5 days to 30 days
measure: Time on ventilator
timeFrame: During hospitalization, approximately 5 days to 30 days
measure: Overall cost of cryo vs PR cryo, when factoring wastage
timeFrame: Daily, approximately 24 months
measure: Number of adverse events: fevers
timeFrame: Within 5 days of surgery start time
measure: Number of adverse events: infections
timeFrame: Within 5 days of surgery start time
measure: Number of adverse events: transfusion reactions
timeFrame: Within 5 days of surgery start time
measure: Fibrinogen level
timeFrame: Most proximal to end of procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Melissa Cushing
role: PRINCIPAL_INVESTIGATOR
References:
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