Cardiac SurgeryRECAPNCT01274390
Impact of Blood Storage Duration on Physiologic Measures
An observational study of Cardiac Surgery and Erythrocyte Transfusion, run by Duke University at 4 sites in United States.
Trial summary
This study is an ancillary (add-on) study to the clinical trial entitled Red Cell Storage Duration Study (RECESS), which has clinicaltrials.gov identifier NCT00991341. The RECESS study randomizes cardiac surgery patients to receive either red blood cell units stored for no more than 10 days, or red blood cell units… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Erythrocyte Transfusion
- How many people
- 390 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2011to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Cardiac surgery patients enrolled in the RECESS study (NCT00991341) at selected hospitals
Who may be able to join
- Eligible and randomized in the RECESS study (NCT00991341)
- At least 18 years old
- Willing to comply with protocol and provide written informed consent for both RECESS and RECAP
- Scheduled to undergo coronary artery bypass (CABG), valve, or combined CABG plus valve surgery
Who cannot join
- Prior randomization into the RECESS or RECAP studies
- Undergoing off-pump cardiac surgery
- Undergoing a significant concomitant surgical procedure
- Known sickle cell disease
- Participation in a clinical trial (except observational studies or RECESS) within the previous 30 days
- Received any investigational product within prior 30 days
- Not able to be randomized in RECESS
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Duke University Medical Center
Durham, North Carolina, 27710
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP)
This study is an ancillary (add-on) study to the clinical trial entitled Red Cell Storage Duration Study (RECESS), which has clinicaltrials.gov identifier NCT00991341. The RECESS study randomizes cardiac surgery patients to receive either red blood cell units stored for no more than 10 days, or red blood cell units stored for at least 21 days, if they need any red blood cell transfusions during their hospital stay for the surgery.
This ancillary study is entitled Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP). The hypothesis of the RECAP study is that there will be differences between the two randomized treatment groups in how much the following measurements change, from shortly before a red blood cell transfusion to shortly after a red blood cell transfusion, and from before surgery to 24 hours after surgery:
Read more
- Oxygen saturation in the hand
- Oxygen saturation in the brain
- Blood flow in the small blood vessels under the tongue.
The RECAP study will also investigate whether changes in the measurements listed above are associated with clinical outcomes, including
- The Multi-Organ Dysfunction Score
- Death from any cause
- Major cardiac events
- Major pulmonary events
- Conditions
- Cardiac Surgery, Erythrocyte Transfusion
- Keywords
- Cardiac Surgery, Red Blood Cell, Transfusion, Oxygen Saturation, Microvascular Flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shorter-storage red blood cell units | Red blood cell units stored <= 10 days | |
| Longer-storage red blood cell units | Red blood cell units stored >= 21 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thenar oxygenation saturation
Measured: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Secondary outcomes (17)
Change in downslope of thenar oxygen saturation
Measured: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in upslope of thenar oxygen saturation
Measured: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in cerebral oxygenation
Measured: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in microvascular mean flow index
Measured: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in percent perfused vessels
Measured: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in capillary density index
Measured: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in thenar oxygen saturation
Measured: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in downslope of thenar oxygen saturation
Measured: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in upslope of thenar oxygen saturation
Measured: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in cerebral oxygenation
Measured: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in microvascular mean flow index
Measured: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in percent perfused vessels
Measured: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in capillary density index
Measured: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in multi-organ dysfunction score
Measured: From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first
All-cause mortality
Measured: Through post-operative Day 28
Composite of major cardiac events
Measured: Through post-operative Day 7, hospital discharge, or death, whichever occurs first
Composite of major pulmonary events
Measured: Through post-operative Day 7, hospital discharge, or death, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Duke 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Elliott Bennett-Guerrero, MD, Principal investigator, Duke UniversityChristopher Stowell, MD, PHD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274390
- Sponsor's protocol ID
- Pro00021198
- Other IDs
- R01HL101382
- Acronym
- RECAP
- Status last verified
- Jul 2014
- First submitted
- 9 Jan 2011
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stowell CP, Whitman G, Granger S, Gomez H, Assmann SF, Massey MJ, Shapiro NI, Steiner ME, Bennett-Guerrero E. The impact of red blood cell storage duration on tissue oxygenation in cardiac surgery. J Thorac Cardiovasc Surg. 2017 Mar;153(3):610-619.e2. doi: 10.1016/j.jtcvs.2016.11.029. Epub 2016 Nov 19.
PubMed 28027790
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP)
- ClinicalTrials.gov ID
- NCT01274390
- Acronym / sponsor ID
- RECAP / Pro00021198
- Conditions
- Cardiac Surgery, Erythrocyte Transfusion
- Keywords
- Cardiac Surgery, Red Blood Cell, Transfusion, Oxygen Saturation, Microvascular Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
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 an ancillary (add-on) study to the clinical trial entitled Red Cell Storage Duration Study (RECESS), which has clinicaltrials.gov identifier NCT00991341. The RECESS study randomizes cardiac surgery patients to receive either red blood cell units stored for no more than 10 days, or red blood cell units stored for at least 21 days, if they need any red blood cell transfusions during their hospital stay for the surgery.
This ancillary study is entitled Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP). The hypothesis of the RECAP study is that there will be differences between the two randomized treatment groups in how much the following measurements change, from shortly before a red blood cell transfusion to shortly after a red blood cell transfusion, and from before surgery to 24 hours after surgery:
- Oxygen saturation in the hand
- Oxygen saturation in the brain
- Blood flow in the small blood vessels under the tongue.
The RECAP study will also investigate whether changes in the measurements listed above are associated with clinical outcomes, including
- The Multi-Organ Dysfunction Score
- Death from any cause
- Major cardiac events
- Major pulmonary events
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shorter-storage red blood cell units | – | –Red blood cell units stored <= 10 days |
| Longer-storage red blood cell units | – | –Red blood cell units stored >= 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients enrolled in the RECESS study (NCT00991341) at selected hospitals
Key inclusion criteria (4 listed)
- Eligible and randomized in the RECESS study (NCT00991341)
- At least 18 years old
- Willing to comply with protocol and provide written informed consent for both RECESS and RECAP
- Scheduled to undergo coronary artery bypass (CABG), valve, or combined CABG plus valve surgery
Key exclusion criteria (7 listed)
- Prior randomization into the RECESS or RECAP studies
- Undergoing off-pump cardiac surgery
- Undergoing a significant concomitant surgical procedure
- Known sickle cell disease
- Participation in a clinical trial (except observational studies or RECESS) within the previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in thenar oxygenation saturation
Time frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
17 secondary outcomes
Change in downslope of thenar oxygen saturation
Time frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in upslope of thenar oxygen saturation
Time frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in cerebral oxygenation
Time frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in microvascular mean flow index
Time frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in percent perfused vessels
Time frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in capillary density index
Time frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in thenar oxygen saturation
Time frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in downslope of thenar oxygen saturation
Time frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in upslope of thenar oxygen saturation
Time frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in cerebral oxygenation
Time frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in microvascular mean flow index
Time frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in percent perfused vessels
Time frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in capillary density index
Time frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Change in multi-organ dysfunction score
Time frame: From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first
All-cause mortality
Time frame: Through post-operative Day 28
Composite of major cardiac events
Time frame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first
Composite of major pulmonary events
Time frame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Results publication: PubMed 28027790Stowell CP, Whitman G, Granger S, Gomez H, Assmann SF, Massey MJ, Shapiro NI, Steiner ME, Bennett-Guerrero E. The impact of red blood cell storage duration on tissue oxygenation in cardiac surgery. J Thorac Cardiovasc Surg. 2017 Mar;153(3):610-619.e2. doi: 10.1016/j.jtcvs.2016.11.029. Epub 2016 Nov 19.
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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.
Elliott Bennett-Guerrero, MD principal investigator
Duke University
Christopher Stowell, MD, PHD principal investigator
Massachusetts General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Erythrocyte Transfusion, run by Duke University at 4 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 7 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in thenar oxygenation saturation (time frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.). 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 NCT01274390, 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 2 Feb 2017.