Blood Transfusion ComplicationsPhase 1/2NCT02094118
Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
A Phase 1/2 study testing Point-of-care washed red blood cell transfusion. in people with Blood Transfusion Complications, run by Mayo Clinic at 2 sites in United States.
Trial summary
This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Transfusion Complications
- What is being tested?
- Point-of-care washed red blood cell transfusion.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to 30 May 2019
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 18 years of age.
- Scheduled to have cardiac bypass surgery at Mayo Clinic in Rochester, Minnesota or Duke University Medical Center in Durham, North Carolina
- At risk for needing at least 4 units of blood during/after surgery
Who cannot join
- Emergency surgery
- Immunoglobulin A (IgA) deficiency
- History of severe recurrent transfusion reactions
- Refusal to receive allogeneic blood products
- Refusal to provide informed consent
- Prevalent lung injury prior to randomization
Show all 14Show fewer
- Prevalent congestive heart failure prior to randomization
- Expected hospital stay < 48 hours
- Not anticipated to survive > 48 hours
- Previously enrolled in this trial
- No plan for placement of a pulmonary artery catheter
- Use of home oxygen therapy
- Complex RBC antibody profiles
- Need for the use of irradiated RBCs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.
- Conditions
- Blood Transfusion Complications
- Being tested
- Point-of-care washed red blood cell transfusion., Standard of care red blood cell transfusion.
- Keywords
- Transfusion, RBC, cardiac, surgery, transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO)
- Medical subject headings
- Transfusion Reaction, Transfusion-Related Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care washed red blood cell transfusion.Biological
Standard of care red blood cell transfusion.Biological
| Study group | Role | What they receive |
|---|---|---|
| Standard of care red blood cell transfusion | Active comparator | Red blood cells that are administered in the normal fashion. Receives: Biological: Standard of care red blood cell transfusion. |
| Point-of-Care washed red blood cell transfusion | Experimental | Red blood cells that are washed at the point-of-care. Receives: Biological: Point-of-care washed red blood cell transfusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.
Measured: 18 hours after the initiation of the first red blood cell transfusion.
Number of "Off-protocol" Transfusions
The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion.
Measured: Day of surgery. Approximately 1 day.
Change in Recipient Hemoglobin
Change in Hemoglobin from pre-transfusion to post-transfusion
Measured: Pre to 6 hours post transfusion
Change in Recipient Cell Free Hemoglobin(CFH)
Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion
Measured: Pre transfusion until study day 5 or hospital discharge, approximately 5 days
Change in Haptoglobin
Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion
Measured: Pre transfusion to study day 5 or hospital discharge, approximately 5 days
Secondary outcomes (5)
Duration of Mechanical Ventilation
Number of hours subject received mechanical ventilation.
Measured: Up to hospital day 28, or discharge, whichever comes first
Duration of Oxygen Supplementation
Number of hours subjects received supplemental oxygen.
Measured: Up to day 28, or hospital discharge, whichever comes first
Sequential Organ Failure Assessment (SOFA) Score
Worst SOFA score between Day 1 and Day 5. SOFA scores range from 0-24 with 0 meaning no organ dysfunction and 24 means severe dysfunction of all organ systems evaluated. Each of 6 organ systems are scored on a 0-4 scale with the cumulative score being the total SOFA score.
Measured: Through postoperative day 5.
Hospital Length of Stay
Number of days subject remained in the hospital following their surgical procedure. If the number of days the subject remained in the hospital exceeded 28, a value of 28 is assigned.
Measured: Up to day 28
Post Transfusion Respiratory Complications.
Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO).
Measured: Up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJan 2016
- Primary completion30 May 2019
- Study completion30 May 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Transfusion ComplicationsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Vitalant Research Institute
- Responsible party
- Principal investigator, Daryl J. Kor, M.D., Mayo Clinic
- Investigators
- Daryl Kor, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094118
- Sponsor's protocol ID
- 13-005965
- Status last verified
- Feb 2021
- First submitted
- 19 Mar 2014
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Warner MA, Welsby IJ, Norris PJ, Silliman CC, Armour S, Wittwer ED, Santrach PJ, Meade LA, Liedl LM, Nieuwenkamp CM, Douthit B, van Buskirk CM, Schulte PJ, Carter RE, Kor DJ. Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery. BMJ Open. 2017 Aug 18;7(8):e016398. doi: 10.1136/bmjopen-2017-016398.
PubMed 28821525
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
- ClinicalTrials.gov ID
- NCT02094118
- Acronym / sponsor ID
- 13-005965
- Conditions
- Blood Transfusion Complications
- Keywords
- Transfusion, RBC, cardiac, surgery, transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Duke University, Vitalant Research Institute
- Study start
- Jan 2016
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care red blood cell transfusion | Active comparator | Biological: Standard of care red blood cell transfusion.Red blood cells that are administered in the normal fashion. |
| Point-of-Care washed red blood cell transfusion | Experimental | Biological: Point-of-care washed red blood cell transfusion.Red blood cells that are washed at the point-of-care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age equal to or greater than 18 years of age.
- Scheduled to have cardiac bypass surgery at Mayo Clinic in Rochester, Minnesota or Duke University Medical Center in Durham, North Carolina
- At risk for needing at least 4 units of blood during/after surgery
Key exclusion criteria (14 listed)
- Emergency surgery
- Immunoglobulin A (IgA) deficiency
- History of severe recurrent transfusion reactions
- Refusal to receive allogeneic blood products
- Refusal to provide informed consent
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 |
|---|---|---|
| Point-of-care washed red blood cell transfusion. | Biological | Point-of-Care washed red blood cell transfusion |
| Standard of care red blood cell transfusion. | Biological | Standard of care red blood cell transfusion |
Primary outcome
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
Time frame: 18 hours after the initiation of the first red blood cell transfusion.
This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.
Number of "Off-protocol" Transfusions
Time frame: Day of surgery. Approximately 1 day.
The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion.
Change in Recipient Hemoglobin
Time frame: Pre to 6 hours post transfusion
Change in Hemoglobin from pre-transfusion to post-transfusion
Change in Recipient Cell Free Hemoglobin(CFH)
Time frame: Pre transfusion until study day 5 or hospital discharge, approximately 5 days
Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion
Change in Haptoglobin
Time frame: Pre transfusion to study day 5 or hospital discharge, approximately 5 days
Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion
5 secondary outcomes
Duration of Mechanical Ventilation
Time frame: Up to hospital day 28, or discharge, whichever comes first
Duration of Oxygen Supplementation
Time frame: Up to day 28, or hospital discharge, whichever comes first
Sequential Organ Failure Assessment (SOFA) Score
Time frame: Through postoperative day 5.
Hospital Length of Stay
Time frame: Up to day 28
Post Transfusion Respiratory Complications.
Time frame: Up to day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28821525Warner MA, Welsby IJ, Norris PJ, Silliman CC, Armour S, Wittwer ED, Santrach PJ, Meade LA, Liedl LM, Nieuwenkamp CM, Douthit B, van Buskirk CM, Schulte PJ, Carter RE, Kor DJ. Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery. BMJ Open. 2017 Aug 18;7(8):e016398. doi: 10.1136/bmjopen-2017-016398.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Blood Transfusion Complications
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Blood Transfusion Strategies During Major Surgery
Perioperative Red Blood Cell Transfusion
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingPhase 2
Neonatal Outcomes on Direct Fetal Intravenous Immunoglobulin During Intrauterine Transfusion for Rhesus Isoimmunization
Hemolytic Disease of the Newborn, Fetal Anemia
Active, not recruitingObservational study
Mechanisms of Anaphylaxis
Anaphylaxis, Allergy
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.
Daryl Kor, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Point-of-care washed red blood cell transfusion. in people with Blood Transfusion Complications, run by Mayo Clinic at 2 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 3 inclusion and 14 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 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2021). 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?
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload. (time frame: 18 hours after the initiation of the first red blood cell transfusion.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02094118, which also lists 1 linked publication.
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 6 Apr 2021.