Impact of Blood Storage Duration on Physiologic Measures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Red Cell Storage Duration Study

NCT00991341

Cardiac Surgery Erythrocyte Transfusion

COMPLETED PHASE3

Blood Storage Related Mortality and Adverse Effects in Trauma Patients

NCT07341139

Transfusion Adverse Reaction Major Trauma Blood Product Transfusion for All Conditions

NOT_YET_RECRUITING

Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications

NCT02094118

Blood Transfusion Complications

COMPLETED PHASE1/PHASE2

The Effect of Red Blood Cells Storage Duration on Biochemical Changes in Pediatric Patients

NCT02724605

Red Blood Cells Transfusion

COMPLETED PHASE2

Clinical Impact of Red Cell Storage Age

NCT05482737

RBC Transfusions

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgery Erythrocyte Transfusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Shorter-storage red blood cell units

Red blood cell units stored \<= 10 days

No interventions assigned to this group

Longer-storage red blood cell units

Red blood cell units stored \>= 21 days

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No