Blood LossNCT01038557
Frozen Red Blood Cell Transfusions in Trauma Patients
A study testing RBC units in people with Blood Loss and Anemia, run by Oregon Health and Science University at 5 sites in United States.
Trial summary
The purpose of this study is to look at red blood cell (RBC) transfusions in trauma patients and evaluate for any differences between the age of the RBCs and how they were stored. The investigators will specifically look for the following differences between study groups: 1. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Blood Loss, Anemia, Trauma
- What is being tested?
- RBC units
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2010to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Trauma Service with an Injury Severity Score > 4
- Require a blood (PRBC) transfusion
- Transfusion is not emergent
- Able to obtain consent from patient or appropriate 3rd party prior to 1st transfusion
Who cannot join
- Inability to adhere to blood age randomization due to limitations of the blood bank inventory
- Bilateral hand injuries that prevent StO2 measurements
- Age < 15
- Pregnancy
- Massive transfusion (=/> 10 units in 24 hours) in last 3 months
- Hemodynamically unstable or need for transfusion in < 3 hours
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Cincinnati
Cincinnati, Ohio
University of Texas Southwestern Medical Center
Dallas, Texas
University of Texas Health Science Center at Houston
Houston, Texas
Oregon Health & Science University
Portland, Oregon, 97239
University of Texas Health Science Center at San Antonio
San Antonio, Texas
About this study
Official title: Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients
The purpose of this study is to look at red blood cell (RBC) transfusions in trauma patients and evaluate for any differences between the age of the RBCs and how they were stored. The investigators will specifically look for the following differences between study groups:
- the transfused red blood cells' ability to delivery oxygen to the tissues
- differences in biochemical markers in subjects and units transfused, and
- how the subject's internal organs are working and if they develop any infections
- Conditions
- Blood Loss, Anemia, Trauma
- Being tested
- RBC units
- Keywords
- frozen, red blood cells, transfusion, trauma
- Medical subject headings
- Hemorrhage, Anemia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBC unitsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Refrigerated RBCs 0-14 days old | Active comparator | Standard, refrigerated RBC units stored up to 14 days Receives: Biological: RBC units |
| Refrigerated RBCs 15-42 days old | Active comparator | Standard, refrigerated RBC units stored 15-42 days Receives: Biological: RBC units |
| Frozen RBCs | Experimental | RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. Receives: Biological: RBC units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Oxygenation
Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.
Measured: Percentage of baseline (3 hours post transfusion compared to baseline)
Secondary outcomes (9)
2,3 DPG Levels After Transfusion
2,3 DPG levels 12 hours after transfusion
Measured: 12 hours post transfusion
Free Hemoglobin Levels After Transfusion
Free hemoglobin levels 12 hours after transfusion
Measured: 12 hours after transfusion
Haptoglobin Levels 12 Hours After Transfusion
Haptoglobin levels after transfusion
Measured: 12 hours after transfusion
Clinical Outcomes - Hospital Days
Clinical outcomes - Number of days admitted to the hospital within a 6 month window.
Measured: from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - ICU Days
Number of days admitted to the ICU during hospital admission
Measured: from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - Ventilator Days
Measured: from time of randomization through hospital discharged, assessed up to 6 months
Number of Participants With Acute Renal Failure
Number of participants who developed acute renal failure while hospitalized.
Measured: from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - Acute Respiratory Distress Syndrome
Number of subjects who developed acute respiratory distress syndrome while hospitalized.
Measured: from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - Infections
Number of subjects who developed infections while hospitalized.
Measured: from time of randomization through hospital discharged, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Air Force, Armed Services Blood Program
- Responsible party
- Principal investigator, Martin A Schreiber, MD, Oregon Health and Science University
- Investigators
- Martin Schreiber, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038557
- Sponsor's protocol ID
- 002-01
- Status last verified
- Jan 2020
- First submitted
- 23 Dec 2009
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients
- ClinicalTrials.gov ID
- NCT01038557
- Acronym / sponsor ID
- 002-01
- Conditions
- Blood Loss, Anemia, Trauma
- Keywords
- frozen, red blood cells, transfusion, trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- United States Air Force, Armed Services Blood Program
- Study start
- Jan 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Posted 28 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at red blood cell (RBC) transfusions in trauma patients and evaluate for any differences between the age of the RBCs and how they were stored. The investigators will specifically look for the following differences between study groups:
- the transfused red blood cells' ability to delivery oxygen to the tissues
- differences in biochemical markers in subjects and units transfused, and
- how the subject's internal organs are working and if they develop any infections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Refrigerated RBCs 0-14 days old | Active comparator | Biological: RBC unitsStandard, refrigerated RBC units stored up to 14 days |
| Refrigerated RBCs 15-42 days old | Active comparator | Biological: RBC unitsStandard, refrigerated RBC units stored 15-42 days |
| Frozen RBCs | Experimental | Biological: RBC unitsRBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Trauma Service with an Injury Severity Score > 4
- Require a blood (PRBC) transfusion
- Transfusion is not emergent
- Able to obtain consent from patient or appropriate 3rd party prior to 1st transfusion
Key exclusion criteria (6 listed)
- Inability to adhere to blood age randomization due to limitations of the blood bank inventory
- Bilateral hand injuries that prevent StO2 measurements
- Age < 15
- Pregnancy
- Massive transfusion (=/> 10 units in 24 hours) in last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBC unitsWhen 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. | Biological | Frozen RBCs, Refrigerated RBCs 0-14 days old, Refrigerated RBCs 15-42 days old |
Primary outcome
Tissue Oxygenation
Time frame: 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.
9 secondary outcomes
2,3 DPG Levels After Transfusion
Time frame: 12 hours post transfusion
Free Hemoglobin Levels After Transfusion
Time frame: 12 hours after transfusion
Haptoglobin Levels 12 Hours After Transfusion
Time frame: 12 hours after transfusion
Clinical Outcomes - Hospital Days
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - ICU Days
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - Ventilator Days
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
Number of Participants With Acute Renal Failure
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - Acute Respiratory Distress Syndrome
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - Infections
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schreiber, MD principal investigator
Oregon Health and Science University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RBC units in people with Blood Loss and Anemia, run by Oregon Health and Science University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Oxygenation (time frame: Percentage of baseline (3 hours post transfusion compared to baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.