Trial Outcomes & Findings for Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding (NCT NCT05711524)

NCT ID: NCT05711524

Last Updated: 2025-11-21

Results Overview

RBCs used over admission

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 208 participants
• Primary outcome timeframe: Within the first 30 days after surgery.
• Results posted on: 2025-11-21

Participant Flow

Unit of analysis: cryo transfusions

Participant milestones

Measure	Patients Given Traditional Cryo These are all liver transplant and cardiothoracic (LT and CT) patients that will be given Traditional Cryo based on the randomization protocol. The blood bank will be randomized by to use either PR Cryo or Traditional Cryo for the entire month for all patients with a Cryo order. The patients included in this arm received Traditional Cryo during a month in which the blood bank was randomized to use Traditional Cryo. The months in which the blood bank was assigned to use Traditional Cryo are as follows: Period 1: Month 1, Period 4: Month 4, Period 5: Month 5, Period 7: Month 7, Period 10: Month 10, and Period 12: Month 12.	Patients Given PR Cryo These are all liver transplant and cardiothoracic (LT and CT) patients that will be given PR Cryo based on the randomization protocol. The blood bank will be randomized by to use either PR Cryo or Traditional Cryo for the entire month for all patients with a Cryo order. The patients included in this arm received PR Cryo during a month in which the blood bank was randomized to use PR Cryo. The months in which the blood bank was assigned to use PR Cryo are as follows: Period 2: Month 2, Period 3: Month 3, Period 6: Month 6, Period 8: Month 8, Period 9: Month 9, Period 11: Month 11.
Month 1 (Traditional Cryo) STARTED	20 50	0 0
Month 1 (Traditional Cryo) COMPLETED	20 50	0 0
Month 1 (Traditional Cryo) NOT COMPLETED	0 0	0 0
Month 2 (PR Cryo) STARTED	0 0	20 45
Month 2 (PR Cryo) COMPLETED	0 0	20 45
Month 2 (PR Cryo) NOT COMPLETED	0 0	0 0
Month 3 (PR Cryo) STARTED	0 0	17 43
Month 3 (PR Cryo) COMPLETED	0 0	17 43
Month 3 (PR Cryo) NOT COMPLETED	0 0	0 0
Month 4 (Traditional Cryo) STARTED	20 42	0 0
Month 4 (Traditional Cryo) COMPLETED	20 42	0 0
Month 4 (Traditional Cryo) NOT COMPLETED	0 0	0 0
Month 5 (Traditional Cryo) STARTED	20 51	0 0
Month 5 (Traditional Cryo) COMPLETED	20 51	0 0
Month 5 (Traditional Cryo) NOT COMPLETED	0 0	0 0
Month 6 (PR Cryo) STARTED	0 0	19 40
Month 6 (PR Cryo) COMPLETED	0 0	19 40
Month 6 (PR Cryo) NOT COMPLETED	0 0	0 0
Month 7 (Traditional Cryo) STARTED	23 41	0 0
Month 7 (Traditional Cryo) COMPLETED	23 41	0 0
Month 7 (Traditional Cryo) NOT COMPLETED	0 0	0 0
Month 8 (PR Cryo) STARTED	0 0	15 28
Month 8 (PR Cryo) COMPLETED	0 0	15 28
Month 8 (PR Cryo) NOT COMPLETED	0 0	0 0
Month 9 (PR Cryo) STARTED	0 0	19 44
Month 9 (PR Cryo) COMPLETED	0 0	19 44
Month 9 (PR Cryo) NOT COMPLETED	0 0	0 0
Month 10 (Traditional Cryo) STARTED	10 21	0 0
Month 10 (Traditional Cryo) COMPLETED	10 21	0 0
Month 10 (Traditional Cryo) NOT COMPLETED	0 0	0 0
Month 11 (PR Cryo) STARTED	0 0	13 38
Month 11 (PR Cryo) COMPLETED	0 0	13 38
Month 11 (PR Cryo) NOT COMPLETED	0 0	0 0
Month 12 (Traditional Cryo) STARTED	12 35	0 0
Month 12 (Traditional Cryo) COMPLETED	12 35	0 0
Month 12 (Traditional Cryo) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.	Total n=208 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 14 • n=68 Participants	61 years STANDARD_DEVIATION 14 • n=76 Participants	61 years STANDARD_DEVIATION 14 • n=48 Participants
Sex: Female, Male Female	39 Participants n=68 Participants	41 Participants n=76 Participants	80 Participants n=48 Participants
Sex: Female, Male Male	66 Participants n=68 Participants	62 Participants n=76 Participants	128 Participants n=48 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=68 Participants	1 Participants n=76 Participants	15 Participants n=48 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	91 Participants n=68 Participants	102 Participants n=76 Participants	193 Participants n=48 Participants
Region of Enrollment United States	105 participants n=68 Participants	103 participants n=76 Participants	208 participants n=48 Participants
ASA Score	3.8 Score on a scale STANDARD_DEVIATION 0.51 • n=68 Participants	3.8 Score on a scale STANDARD_DEVIATION 0.43 • n=76 Participants	3.8 Score on a scale STANDARD_DEVIATION 0.47 • n=48 Participants

PRIMARY outcome

Timeframe: Within the first 30 days after surgery.

RBCs used over admission

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Total Number of RBCs Used Over Admission	5.8 RBC Units Standard Deviation 6.5	6.7 RBC Units Standard Deviation 7.2

PRIMARY outcome

Timeframe: Within the first 30 days after surgery.

Plts used over admission

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Total Number of Platelets Used Over Admission	2.1 platelet units Standard Deviation 3.1	2.1 platelet units Standard Deviation 2.0

PRIMARY outcome

Timeframe: Within the first 30 days after surgery.

All units over admission

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Total Number of Plasma Used Over Admission	2.7 plasma units Standard Deviation 4.6	3.4 plasma units Standard Deviation 6.0

SECONDARY outcome

Timeframe: 3 days post procedure

All products within 3 days

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Number of Cryo Units Used Perioperatively	2.3 cryo units Standard Deviation 1.7	2.3 cryo units Standard Deviation 1.6

SECONDARY outcome

Timeframe: 3 days post procedure

Number of RBC units transfused during perioperative period

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Number of RBCs Used Perioperatively	4.6 RBC units Standard Deviation 5.6	5.9 RBC units Standard Deviation 6.6

SECONDARY outcome

Timeframe: 3 days post procedure

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Number of Plasma Used Perioperatively	2.6 plasma units Standard Deviation 4.6	3.4 plasma units Standard Deviation 6.01

SECONDARY outcome

Timeframe: 3 days post procedure

Number of platelet units transfused during perioperative period

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Number of Platelets Used Perioperatively	1.8 platelet units Standard Deviation 1.7	2.0 platelet units Standard Deviation 1.8

SECONDARY outcome

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

Population: Only the cardiac population was included for this analysis. The data was not available for liver transplant patients, so liver transplant patients were excluded from the analysis.

Outcome measures

Measure	Patients Given Traditional Cryo n=86 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=84 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Time From Operating Room (OR) Start Time to Start of Cryo Transfusion	366 minutes Interval 309.0 to 425.0	367 minutes Interval 324.0 to 416.0

SECONDARY outcome

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

Time to cryo order time to start of cryo transfusion

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Time From Cryo Order to Start of Transfusion	128.3 minutes Standard Deviation 200.7	88.5 minutes Standard Deviation 99.8

SECONDARY outcome

Timeframe: Daily, up to approximately 24 months

Population: The blood bank, which is required to follow its standard operating procedures, was not able to document wastage in a way which allowed the investigators to accurately attribute wastage to a specific arm of the study. Therefore, wastage could not be accurately calculated as intended in the study protocol.

This captures the Cryoprecipitate units discarded.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data for all participants was not available because pre-transfusion FIBTEMs were not clinically ordered for all participants by the treating anesthesiologists. Only participants with pre-transfusion FIBTEMs available were included in this analysis.

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.

Outcome measures

Measure	Patients Given Traditional Cryo n=95 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=94 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation	9.6 mm Standard Deviation 6.8	8.3 mm Standard Deviation 4.2

SECONDARY outcome

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

Population: Data were not available nor collected for this measure because anesthesiologists do not routinely order this for the investigators to have been able to collect it.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data for MCF were not collected since clinical decisions are not made based on this value as the measure assumed. As such, there are no data to report. Clinical decisions were made based on A10 (the clot amplitude measured 10 minutes after clot formation start), not the maximum clot firmness (MCF). As A10 was not a pre-specified measure for this protocol, there are no data to report. Data will never be collected for this Outcome Measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Some data were not collected for this measure because anesthesiologists did not routinely order this test.

The fibrinogen measurement before cryoprecipitate is transfused.

Outcome measures

Measure	Patients Given Traditional Cryo n=10 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=9 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Pre-transfusion Fibrinogen Level	145 mg/dL Standard Deviation 68	191 mg/dL Standard Deviation 33

SECONDARY outcome

Timeframe: Within 24 hours after surgery

Population: Some data were not collected for this measure because anesthesiologists did not always order this test.

Outcome measures

Measure	Patients Given Traditional Cryo n=100 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=100 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Highest Fibrinogen Level Within 24 Hours	210 mg/dL Standard Deviation 53	212 mg/dL Standard Deviation 46

SECONDARY outcome

Timeframe: Within 24 hours after surgery

Population: Some data were not collected for this measure because anesthesiologists did not always order this test.

Outcome measures

Measure	Patients Given Traditional Cryo n=100 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=100 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Lowest Fibrinogen Level Within 24 Hours	194.5 mg/dL Standard Deviation 51.0	199.89 mg/dL Standard Deviation 44.3

SECONDARY outcome

Timeframe: Up to approximately 3 days

Population: This data were not available for collection in the electronic health record as intended by the investigators, as the data were not clinically documented. Therefore, the cumulative volume in drains after surgery could not be reported as intended in the study protocol.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 24 hours after surgery

Population: Only the cardiac population was included for this analysis. The clinical parameter is not applicable to liver transplant patients, so liver transplant patients were excluded from the analysis.

Outcome measures

Measure	Patients Given Traditional Cryo n=85 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=83 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Volume in Drains (Chest Tube for CV Surgery)	897 mLs Standard Deviation 810	749 mLs Standard Deviation 496

SECONDARY outcome

Timeframe: Until end of surgery

Population: Only for cardiac surgery patients. Liver transplant patients are not on bypass.

Outcome measures

Measure	Patients Given Traditional Cryo n=86 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=84 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Time From End of Bypass Pump for CV Surgery	2.75 hours Interval 2.32 to 3.27	2.73 hours Interval 2.46 to 3.22

SECONDARY outcome

Timeframe: Duration of time in operating room

Operating room length of stay

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Length of Stay in OR	522 minutes Standard Deviation 124	534 minutes Standard Deviation 118

SECONDARY outcome

Timeframe: During hospitalization, approximately 5 days to 30 days

Participant length of stay in ICU setting

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Length of Stay in ICU	8.1 days Standard Deviation 11.8	6.9 days Standard Deviation 8.6

SECONDARY outcome

Timeframe: During hospitalization, approximately 5 days to 30 days

Overall length of stay in hospital

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Length of Stay in Hospital	12.0 days Standard Deviation 9.4	10.9 days Standard Deviation 10.1

SECONDARY outcome

Timeframe: During hospitalization, approximately 5 days to 30 days

Population: Not all values available in the electronic health record.

Outcome measures

Measure	Patients Given Traditional Cryo n=100 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=98 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Need for Ventilator	99 Participants	96 Participants

SECONDARY outcome

Timeframe: During hospitalization, approximately 5 days to 30 days

Population: Not all values available in the electronic health record.

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

Outcome measures

Measure	Patients Given Traditional Cryo n=99 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=96 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Time on Ventilator	2.4 days Standard Deviation 4.9	2.6 days Standard Deviation 6.3

SECONDARY outcome

Timeframe: Daily, approximately 24 months

Population: Not available due to unavailable confidential contractual information that would be needed to calculate cost. The contract between the blood suppliers and hospital is confidential, and therefore the investigators were not able to report on cost-related factors as intended in the study protocol. Data will never be collected for this Outcome Measure.

Cost of traditional cryoprecipitate compared to PR Cryoprecipitate.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 5 days of surgery start time

All participants that experience fevers that occur during the time frame

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Number of Participants That Experienced an Adverse Event of Fever	16 Participants	14 Participants

SECONDARY outcome

Timeframe: Within 5 days of surgery start time

All participants that experience infections that occur during the time frame

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Number of Participants That Experienced an Adverse Event of Infection	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Within 5 days of surgery start time

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

Outcome measures

Measure	Patients Given Traditional Cryo n=105 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Number of Participants That Experienced an Adverse Event of Transfusion Reaction.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Most proximal to end of procedure

Population: Fibrinogen was not ordered by provider for every participant

Fibrinogen level most proximal to the end of surgery

Outcome measures

Measure	Patients Given Traditional Cryo n=101 Participants 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=101 Participants 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Fibrinogen Level	197 mg/dL Standard Deviation 52	201 mg/dL Standard Deviation 38

Adverse Events

Patients Given Traditional Cryo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 5 deaths

Patients Given PR Cryo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 2 deaths

Serious adverse events

Measure	Patients Given Traditional Cryo n=105 participants at risk 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 participants at risk 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Blood and lymphatic system disorders Transfusion Reactions	0.00% 0/105 • Serious adverse events: 5 days post-procedure. All cause-mortality: 30 days or discharge from hospital, whichever occurred first. Serious adverse events collected included transfusion reactions. Adverse events collected included fevers and infections. Data were collected using automated scripts with Structured Query Language (SQL) queries of the hospital's centralized data warehouse. Adverse events were assessed weekly by the study team via video conference.	0.00% 0/103 • Serious adverse events: 5 days post-procedure. All cause-mortality: 30 days or discharge from hospital, whichever occurred first. Serious adverse events collected included transfusion reactions. Adverse events collected included fevers and infections. Data were collected using automated scripts with Structured Query Language (SQL) queries of the hospital's centralized data warehouse. Adverse events were assessed weekly by the study team via video conference.

Other adverse events

Measure	Patients Given Traditional Cryo n=105 participants at risk 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. Traditional Cryoprecipitate: This is the cryoprecipitate already currently being given to patients with a cryo order.	Patients Given PR Cryo n=103 participants at risk 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. Pathogen-Reduced Cryoprecipitate: This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
Infections and infestations Infection	5.7% 6/105 • Number of events 6 • Serious adverse events: 5 days post-procedure. All cause-mortality: 30 days or discharge from hospital, whichever occurred first. Serious adverse events collected included transfusion reactions. Adverse events collected included fevers and infections. Data were collected using automated scripts with Structured Query Language (SQL) queries of the hospital's centralized data warehouse. Adverse events were assessed weekly by the study team via video conference.	3.9% 4/103 • Number of events 4 • Serious adverse events: 5 days post-procedure. All cause-mortality: 30 days or discharge from hospital, whichever occurred first. Serious adverse events collected included transfusion reactions. Adverse events collected included fevers and infections. Data were collected using automated scripts with Structured Query Language (SQL) queries of the hospital's centralized data warehouse. Adverse events were assessed weekly by the study team via video conference.
Infections and infestations Fever	15.2% 16/105 • Number of events 16 • Serious adverse events: 5 days post-procedure. All cause-mortality: 30 days or discharge from hospital, whichever occurred first. Serious adverse events collected included transfusion reactions. Adverse events collected included fevers and infections. Data were collected using automated scripts with Structured Query Language (SQL) queries of the hospital's centralized data warehouse. Adverse events were assessed weekly by the study team via video conference.	13.6% 14/103 • Number of events 14 • Serious adverse events: 5 days post-procedure. All cause-mortality: 30 days or discharge from hospital, whichever occurred first. Serious adverse events collected included transfusion reactions. Adverse events collected included fevers and infections. Data were collected using automated scripts with Structured Query Language (SQL) queries of the hospital's centralized data warehouse. Adverse events were assessed weekly by the study team via video conference.

Additional Information

Dr. Melissa Cushing

Weill Cornell Medicine

Phone: 212-746-3527

Email: mec2013@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place