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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
This is the cryoprecipitate already currently being given to patients with a cryo order.
This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Total Number of RBCs Used Over Admission
RBCs used over admission
Time frame: Within the first 30 days after surgery.
Total Number of Platelets Used Over Admission
Plts used over admission
Time frame: Within the first 30 days after surgery.
Total Number of Plasma Used Over Admission
All units over admission
Time frame: Within the first 30 days after surgery.
Number of Cryo Units Used Perioperatively
All products within 3 days
Time frame: 3 days post procedure
Number of RBCs Used Perioperatively
Number of RBC units transfused during perioperative period
Time frame: 3 days post procedure
Number of Plasma Used Perioperatively
Time frame: 3 days post procedure
Number of Platelets Used Perioperatively
Number of platelet units transfused during perioperative period
Time frame: 3 days post procedure
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)
Time From Cryo Order to Start of Transfusion
Time to cryo order time to start of cryo transfusion
Time frame: procedure (Time from cryo order to start of transfusion)
Number of Cryo Units Wasted by Blood Bank
This captures the Cryoprecipitate units discarded.
Time frame: Daily, up to approximately 24 months
Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation
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.
Time frame: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.
Post Transfusion FIBTEM Amplitude at 10 Min After Start of Clot Formation
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.
Time frame: Variable, but it is generally available within 15 minutes of the start of ROTEM testing.
Maximum Clot Firmness (MCF)
The maximum strength of a clot as determined by ROTEM testing.
Time frame: Variable, but it is generally available within 1 hour of the start of ROTEM testing.
Pre-transfusion Fibrinogen Level
The fibrinogen measurement before cryoprecipitate is transfused.
Time frame: During surgery, within 3 hours of specimen receipt by laboratory.
Highest Fibrinogen Level Within 24 Hours
Time frame: Within 24 hours after surgery
Lowest Fibrinogen Level Within 24 Hours
Time frame: Within 24 hours after surgery
Cumulative Volume in Drains After Surgery (e.g., Chest Tube for CV Surgery) at the Time of Removal
The cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of drain removal
Time frame: Up to approximately 3 days
Volume in Drains (Chest Tube for CV Surgery)
Time frame: At 24 hours after surgery
Time From End of Bypass Pump for CV Surgery
Time frame: Until end of surgery
Length of Stay in OR
Operating room length of stay
Time frame: Duration of time in operating room
Length of Stay in ICU
Participant length of stay in ICU setting
Time frame: During hospitalization, approximately 5 days to 30 days
Length of Stay in Hospital
Overall length of stay in hospital
Time frame: During hospitalization, approximately 5 days to 30 days
Need for Ventilator
Time frame: During hospitalization, approximately 5 days to 30 days
Time on Ventilator
If participant was on ventilator, amount of time spent on ventilator
Time frame: During hospitalization, approximately 5 days to 30 days
Overall Cost of Cryo vs PR Cryo, When Factoring Wastage
Cost of traditional cryoprecipitate compared to PR Cryoprecipitate.
Time frame: Daily, approximately 24 months
Number of Participants That Experienced an Adverse Event of Fever
All participants that experience fevers that occur during the time frame
Time frame: Within 5 days of surgery start time
Number of Participants That Experienced an Adverse Event of Infection
All participants that experience infections that occur during the time frame
Time frame: Within 5 days of surgery start time
Number of Participants That Experienced an Adverse Event of Transfusion Reaction.
All participants that experience transfusion reactions that occur during the time frame
Time frame: Within 5 days of surgery start time
Fibrinogen Level
Fibrinogen level most proximal to the end of surgery
Time frame: Most proximal to end of procedure
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