Trial Outcomes & Findings for Frozen Red Blood Cell Transfusions in Trauma Patients (NCT NCT01038557)

NCT ID: NCT01038557

Last Updated: 2020-01-28

Results Overview

Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 254 participants
• Primary outcome timeframe: Percentage of baseline (3 hours post transfusion compared to baseline)
• Results posted on: 2020-01-28

Participant Flow

Participant milestones

Measure	Frozen RBCs RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 0-14 Days Old Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Overall Study STARTED	86	82	86
Overall Study COMPLETED	86	82	86
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Refrigerated RBCs 0-14 Days Old n=82 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=86 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=86 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Total n=254 Participants Total of all reporting groups
Age, Continuous	52.3 years n=82 Participants	47.9 years n=86 Participants	49.3 years n=86 Participants	49.3 years n=254 Participants
Sex: Female, Male Female	32 Participants n=82 Participants	40 Participants n=86 Participants	29 Participants n=86 Participants	101 Participants n=254 Participants
Sex: Female, Male Male	50 Participants n=82 Participants	46 Participants n=86 Participants	57 Participants n=86 Participants	153 Participants n=254 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	82 participants n=82 Participants	86 participants n=86 Participants	86 participants n=86 Participants	254 participants n=254 Participants
Injury Severity Score	19 units on a scale (1 best to 75 worst) n=82 Participants	19 units on a scale (1 best to 75 worst) n=86 Participants	19 units on a scale (1 best to 75 worst) n=86 Participants	19 units on a scale (1 best to 75 worst) n=254 Participants

PRIMARY outcome

Timeframe: Percentage of baseline (3 hours post transfusion compared to baseline)

Population: Mean percent change in tissue oxygenation (StO2) over time is reported for subjects with continuous data. Data on subjects whose NIRS device fell off or there was discontinuity in recording were excluded.

Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=76 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=73 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=82 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Tissue Oxygenation	100.3 percentage of baseline Standard Deviation 7.2	98.2 percentage of baseline Standard Deviation 11.4	98.3 percentage of baseline Standard Deviation 14.1

SECONDARY outcome

Timeframe: 12 hours post transfusion

Population: Blood samples to measure 2,3 DPG levels could not be collected from all subjects 12 hours after transfusion or results were not measurable.

2,3 DPG levels 12 hours after transfusion

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=60 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=75 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=70 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
2,3 DPG Levels After Transfusion	0.33 g/L Interval 0.22 to 0.47	0.36 g/L Interval 0.25 to 0.47	0.31 g/L Interval 0.23 to 0.56

SECONDARY outcome

Timeframe: 12 hours after transfusion

Population: Blood samples to measure free hemoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.

Free hemoglobin levels 12 hours after transfusion

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=63 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=75 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=69 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Free Hemoglobin Levels After Transfusion	201 ug/mL Interval 86.0 to 422.0	194 ug/mL Interval 106.0 to 194.0	174 ug/mL Interval 82.0 to 287.0

SECONDARY outcome

Timeframe: 12 hours after transfusion

Population: Blood samples to measure haptoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.

Haptoglobin levels after transfusion

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=62 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=75 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=69 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Haptoglobin Levels 12 Hours After Transfusion	897 ng/mL Interval 349.0 to 1775.0	1470 ng/mL Interval 494.0 to 2360.0	1350 ng/mL Interval 411.0 to 2700.0

SECONDARY outcome

Timeframe: from time of randomization through hospital discharged, assessed up to 6 months

Clinical outcomes - Number of days admitted to the hospital within a 6 month window.

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=82 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=86 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=86 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Clinical Outcomes - Hospital Days	13 days Interval 8.0 to 20.5	13.5 days Interval 9.0 to 22.0	18 days Interval 10.0 to 26.0

SECONDARY outcome

Timeframe: from time of randomization through hospital discharged, assessed up to 6 months

Number of days admitted to the ICU during hospital admission

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=82 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=86 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=86 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Clinical Outcomes - ICU Days	6 days Interval 2.0 to 11.0	5 days Interval 2.0 to 11.0	7 days Interval 3.0 to 14.5

SECONDARY outcome

Timeframe: from time of randomization through hospital discharged, assessed up to 6 months

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=82 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=86 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=86 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Clinical Outcomes - Ventilator Days	0 days Interval 0.0 to 4.5	0 days Interval 0.0 to 4.25	1 days Interval 0.0 to 9.5

SECONDARY outcome

Timeframe: from time of randomization through hospital discharged, assessed up to 6 months

Number of participants who developed acute renal failure while hospitalized.

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=82 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=85 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=86 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Number of Participants With Acute Renal Failure	7 Participants	7 Participants	10 Participants

SECONDARY outcome

Timeframe: from time of randomization through hospital discharged, assessed up to 6 months

Number of subjects who developed acute respiratory distress syndrome while hospitalized.

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=82 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=85 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=86 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Clinical Outcomes - Acute Respiratory Distress Syndrome	5 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: from time of randomization through hospital discharged, assessed up to 6 months

Number of subjects who developed infections while hospitalized.

Outcome measures

Measure	Refrigerated RBCs 0-14 Days Old n=82 Participants Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=85 Participants Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=86 Participants RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Clinical Outcomes - Infections	24 Participants	22 Participants	24 Participants

Adverse Events

Refrigerated RBCs 0-14 Days Old

Serious events: 5 serious events

Other events: 24 other events

Deaths: 3 deaths

Refrigerated RBCs 15-42 Days Old

Serious events: 6 serious events

Other events: 22 other events

Deaths: 3 deaths

Frozen RBCs

Serious events: 8 serious events

Other events: 24 other events

Deaths: 3 deaths

Serious adverse events

Measure	Refrigerated RBCs 0-14 Days Old n=82 participants at risk Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=85 participants at risk；n=86 participants at risk Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=86 participants at risk RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
General disorders Pulmonary Embolism	3.7% 3/82 • Number of events 3 • Adverse event data was collected during the patient's hospital admission, up to 6 months.	7.0% 6/86 • Number of events 6 • Adverse event data was collected during the patient's hospital admission, up to 6 months.	5.8% 5/86 • Number of events 5 • Adverse event data was collected during the patient's hospital admission, up to 6 months.
General disorders Sepsis	6.1% 5/82 • Number of events 5 • Adverse event data was collected during the patient's hospital admission, up to 6 months.	7.0% 6/86 • Number of events 6 • Adverse event data was collected during the patient's hospital admission, up to 6 months.	9.3% 8/86 • Number of events 8 • Adverse event data was collected during the patient's hospital admission, up to 6 months.

Other adverse events

Measure	Refrigerated RBCs 0-14 Days Old n=82 participants at risk Standard, refrigerated RBC units stored up to 14 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Refrigerated RBCs 15-42 Days Old n=85 participants at risk；n=86 participants at risk Standard, refrigerated RBC units stored 15-42 days RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.	Frozen RBCs n=86 participants at risk RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Infections and infestations Infection	29.3% 24/82 • Number of events 24 • Adverse event data was collected during the patient's hospital admission, up to 6 months.	25.9% 22/85 • Number of events 22 • Adverse event data was collected during the patient's hospital admission, up to 6 months.	27.9% 24/86 • Number of events 24 • Adverse event data was collected during the patient's hospital admission, up to 6 months.
General disorders Deep Vein Thrombosis	17.1% 14/82 • Number of events 14 • Adverse event data was collected during the patient's hospital admission, up to 6 months.	15.3% 13/85 • Number of events 13 • Adverse event data was collected during the patient's hospital admission, up to 6 months.	16.3% 14/86 • Number of events 14 • Adverse event data was collected during the patient's hospital admission, up to 6 months.

Additional Information

Dr. Martin A. Schreiber

Oregon Health & Science University

Phone: 503-494-8324

Email: schreibm@ohsu.edu

Results disclosure agreements

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