Trial · NCT01038557

Frozen Red Blood Cell Transfusions in Trauma Patients

NCT01038557, Not applicable, Completed, Oregon Health and Science University; results first posted 2020-01-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Frozen Red Blood Cell Transfusions in Trauma Patients. Trials, record NCT01038557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01038557

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Frozen Red Blood Cell Transfusions in Trauma Patients
NCT number: NCT01038557
Status: Completed
Phases: Not applicable
Enrollment: 254 participants, actual
Lead sponsor: Oregon Health and Science University
Conditions: Blood Loss, Anemia, Trauma
Interventions: RBC units
First posted: 2009-12-24
Last updated: 2020-01-28
Results first posted: 2020-01-28

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Tissue Oxygenation	Percentage of baseline (3 hours post transfusion compared to baseline)	Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.
Secondary	2,3 DPG Levels After Transfusion	12 hours post transfusion	2,3 DPG levels 12 hours after transfusion
Secondary	Free Hemoglobin Levels After Transfusion	12 hours after transfusion	Free hemoglobin levels 12 hours after transfusion
Secondary	Haptoglobin Levels 12 Hours After Transfusion	12 hours after transfusion	Haptoglobin levels after transfusion
Secondary	Clinical Outcomes - Hospital Days	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.
Secondary	Clinical Outcomes - ICU Days	from time of randomization through hospital discharged, assessed up to 6 months	Number of days admitted to the ICU during hospital admission
Secondary	Clinical Outcomes - Ventilator Days	from time of randomization through hospital discharged, assessed up to 6 months
Secondary	Number of Participants With Acute Renal Failure	from time of randomization through hospital discharged, assessed up to 6 months	Number of participants who developed acute renal failure while hospitalized.
Secondary	Clinical Outcomes - Acute Respiratory Distress Syndrome	from time of randomization through hospital discharged, assessed up to 6 months	Number of subjects who developed acute respiratory distress syndrome while hospitalized.
Secondary	Clinical Outcomes - Infections	from time of randomization through hospital discharged, assessed up to 6 months	Number of subjects who developed infections while hospitalized.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Tissue Oxygenation	Percentage of baseline (3 hours post transfusion compared to baseline)	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.	percentage of baseline	MEAN
SECONDARY	2,3 DPG Levels After Transfusion	12 hours post transfusion	Blood samples to measure 2,3 DPG levels could not be collected from all subjects 12 hours after transfusion or results were not measurable.	g/L	MEDIAN
SECONDARY	Free Hemoglobin Levels After Transfusion	12 hours after transfusion	Blood samples to measure free hemoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.	ug/mL	MEDIAN
SECONDARY	Haptoglobin Levels 12 Hours After Transfusion	12 hours after transfusion	Blood samples to measure haptoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.	ng/mL	MEDIAN
SECONDARY	Clinical Outcomes - Hospital Days	from time of randomization through hospital discharged, assessed up to 6 months		days	MEDIAN
SECONDARY	Clinical Outcomes - ICU Days	from time of randomization through hospital discharged, assessed up to 6 months		days	MEDIAN
SECONDARY	Clinical Outcomes - Ventilator Days	from time of randomization through hospital discharged, assessed up to 6 months		days	MEDIAN
SECONDARY	Number of Participants With Acute Renal Failure	from time of randomization through hospital discharged, assessed up to 6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Outcomes - Acute Respiratory Distress Syndrome	from time of randomization through hospital discharged, assessed up to 6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Outcomes - Infections	from time of randomization through hospital discharged, assessed up to 6 months		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Tissue Oxygenation	Refrigerated RBCs 0-14 Days Old	100.3	Standard Deviation 7.2	percentage of baseline
Tissue Oxygenation	Refrigerated RBCs 15-42 Days Old	98.2	Standard Deviation 11.4	percentage of baseline
Tissue Oxygenation	Frozen RBCs	98.3	Standard Deviation 14.1	percentage of baseline
2,3 DPG Levels After Transfusion	Refrigerated RBCs 0-14 Days Old	0.33	Inter-Quartile Range 0.22 to 0.47	g/L
2,3 DPG Levels After Transfusion	Refrigerated RBCs 15-42 Days Old	0.36	Inter-Quartile Range 0.25 to 0.47	g/L
2,3 DPG Levels After Transfusion	Frozen RBCs	0.31	Inter-Quartile Range 0.23 to 0.56	g/L
Free Hemoglobin Levels After Transfusion	Refrigerated RBCs 0-14 Days Old	201	Inter-Quartile Range 86 to 422	ug/mL
Free Hemoglobin Levels After Transfusion	Refrigerated RBCs 15-42 Days Old	194	Inter-Quartile Range 106 to 194	ug/mL
Free Hemoglobin Levels After Transfusion	Frozen RBCs	174	Inter-Quartile Range 82 to 287	ug/mL
Haptoglobin Levels 12 Hours After Transfusion	Refrigerated RBCs 0-14 Days Old	897	Inter-Quartile Range 349 to 1775	ng/mL

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Refrigerated RBCs 0-14 Days Old	82
Overall Study	STARTED	Refrigerated RBCs 15-42 Days Old	86
Overall Study	STARTED	Frozen RBCs	86
Overall Study	COMPLETED	Refrigerated RBCs 0-14 Days Old	82
Overall Study	COMPLETED	Refrigerated RBCs 15-42 Days Old	86
Overall Study	COMPLETED	Frozen RBCs	86
Overall Study	NOT COMPLETED	Refrigerated RBCs 0-14 Days Old	0
Overall Study	NOT COMPLETED	Refrigerated RBCs 15-42 Days Old	0
Overall Study	NOT COMPLETED	Frozen RBCs	0

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Infection	Infections and infestations	Refrigerated RBCs 0-14 Days Old	24	82	24
other	Infection	Infections and infestations	Refrigerated RBCs 15-42 Days Old	22	85	22
other	Infection	Infections and infestations	Frozen RBCs	24	86	24
other	Deep Vein Thrombosis	General disorders	Refrigerated RBCs 0-14 Days Old	14	82	14
other	Deep Vein Thrombosis	General disorders	Refrigerated RBCs 15-42 Days Old	13	85	13
other	Deep Vein Thrombosis	General disorders	Frozen RBCs	14	86	14
serious	Pulmonary Embolism	General disorders	Refrigerated RBCs 0-14 Days Old	3	82	3
serious	Pulmonary Embolism	General disorders	Refrigerated RBCs 15-42 Days Old	6	86	6
serious	Pulmonary Embolism	General disorders	Frozen RBCs	5	86	5
serious	Sepsis	General disorders	Refrigerated RBCs 0-14 Days Old	5	82	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Refrigerated RBCs 0-14 Days Old	3	82
Total, all-cause mortality	Refrigerated RBCs 15-42 Days Old	3	86
Total, all-cause mortality	Frozen RBCs	3	86
Total, other adverse events	Refrigerated RBCs 0-14 Days Old	24	82
Total, other adverse events	Refrigerated RBCs 15-42 Days Old	22	85
Total, other adverse events	Frozen RBCs	24	86
Total, serious adverse events	Refrigerated RBCs 0-14 Days Old	5	82
Total, serious adverse events	Refrigerated RBCs 15-42 Days Old	6	86
Total, serious adverse events	Frozen RBCs	8	86

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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