Impact of Blood Storage Duration on Physiologic Measures (RECAP)
This study is currently recruiting participants.
Verified November 2012 by Duke University
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01274390
First received: January 9, 2011
Last updated: November 27, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP) |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Change in multi-organ dysfunction score [ Time Frame: From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: Through post-operative Day 28 ] [ Designated as safety issue: No ]
- Composite of major cardiac events [ Time Frame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
- Composite of major pulmonary events [ Time Frame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 390 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Cardiac surgery patients enrolled in the RECESS study (NCT00991341) at selected hospitals
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274390
Contacts
| Contact: Elliott Bennett-Guerrero, MD | 919-681-0841 | benne011@mc.duke.edu |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Christopher Stowell, MD, PHD 617-726-6832 cstowell@partners.org | |
| Principal Investigator: Christopher Stowell, MD, PHD | |
| Brigham and Womens Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Richard M Kaufman, MD 617-732-5232 rmkaufman@partners.org | |
| Principal Investigator: Richard M Kaufman, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Marie Steiner, MD 612-626-2778 stein083@umn.edu | |
| Principal Investigator: Marie Steiner, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Elliott Bennett-Guerrero, MD 919-681-0841 benne011@mc.duke.edu | |
| Principal Investigator: Elliott Bennett-Guerrero, MD | |
Sponsors and Collaborators
Duke University
Investigators
| Principal Investigator: | Elliott Bennett-Guerrero, MD | Duke University |
| Principal Investigator: | Christopher Stowell, MD, PHD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01274390 History of Changes |
| Other Study ID Numbers: | Pro00021198, R01HL101382 |
| Study First Received: | January 9, 2011 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Duke University:
|
Cardiac Surgery Red Blood Cell Transfusion Oxygen Saturation Microvascular Flow |
ClinicalTrials.gov processed this record on May 21, 2013