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NCT Number: NCT01274390

Impact of Blood Storage Duration on Physiologic Measures

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

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Key information

Conditions

Cardiac Surgery Erythrocyte Transfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Womens Hospital, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Change in multi-organ dysfunction score

    Time frame: From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first

  15. All-cause mortality

    Time frame: Through post-operative Day 28

  16. Composite of major cardiac events

    Time frame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first

  17. Composite of major pulmonary events

    Time frame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP)

Acronym: RECAP

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2011
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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