Impact of Blood Storage Duration on Physiologic Measures

Cardiac Surgery Clinical Trial

— RECAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274390
• Other study ID #: Pro00021198
• Secondary ID: R01HL101382
• Status: Completed
• Phase: N/A
• First received: January 9, 2011
• Last updated: February 1, 2017
• Start date: January 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Erythrocyte Transfusion

Locations

Country	Name	City	State
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & 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. 2016 Nov 19. pii: S0022-5223(16 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Change in capillary density index		From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Secondary	Change in thenar oxygen saturation		From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Secondary	Change in downslope of thenar oxygen saturation		From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Secondary	Change in upslope of thenar oxygen saturation		From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Secondary	Change in cerebral oxygenation		From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Secondary	Change in microvascular mean flow index		From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Secondary	Change in percent perfused vessels		From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Secondary	Change in capillary density index		From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
Secondary	Change in multi-organ dysfunction score		From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first
Secondary	All-cause mortality		Through post-operative Day 28
Secondary	Composite of major cardiac events		Through post-operative Day 7, hospital discharge, or death, whichever occurs first
Secondary	Composite of major pulmonary events		Through post-operative Day 7, hospital discharge, or death, whichever occurs first