Impact of Blood Storage Duration on Physiologic Measures

NCT01274390 | Completed DMC

• 2 other identifiers: Pro00021198R01HL101382
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 4

Brief 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 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

Conditions

Cardiac Surgery; Erythrocyte Transfusion

Keywords

Cardiac Surgery; Red Blood Cell; Transfusion; Oxygen Saturation; Microvascular Flow

Outcome Measures

Primary Outcomes (1)

• Change in thenar oxygenation saturation

  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

  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

  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

  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

  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

  From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac surgery patients enrolled in the RECESS study (NCT00991341) at selected hospitals

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 28027790 RESULT

Study Officials

• Elliott Bennett-Guerrero, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Christopher Stowell, MD, PHD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2011
• First Posted: January 11, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 2, 2017

Record last verified: 2014-07

Locations

US (4)