Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

N/A

Waitlist Available

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* All primary and reoperative adult cardiac surgical patients undergoing cardiopulmonary bypass for coronary artery bypass grafting, coronary artery bypass grafting with a valve procedure, isolated valve procedures and ascending aortic repair for aneurysm or dissection procedures.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after surgeyr until hospital discharge

Awards & highlights

No Placebo-Only Group

Summary

The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery. The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after surgery until hosptal discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after surgery until hosptal discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and after surgery until hosptal discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

A Composite of In-hospital Postoperative Morbidity and Mortality

Secondary study objectives

Prolonged Postoperative Ventilation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Blood transfusion triggers of 24% hematocrit valueActive Control1 Intervention

Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.

Group II: Blood transfusion triggers of 28% hematocrit valueActive Control1 Intervention

Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.

0 / 1Eligibility criteria met