Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

Anemia Clinical Trial

Official title:

Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651573
• Other study ID #: 08-064
• Status: Completed
• Phase: N/A
• Start date: March 2007
• Est. completion date: January 3, 2019

Study information

• Verified date: March 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their HCT value.

Hematocrit Groups:

1. 24%

2. 28%

Red blood cell transfusion will be given only when hematocrit values fall below the assigned group value. When the hematocrit value falls to a value less than the value for the randomized group 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 the randomized group no further transfusions will be administered. A measurement of the patient's HCT after each unit of RBC administered is required prior to administering additional units. If a patient's hematocrit is greater than the value for the group which they are randomized, no transfusion of RBC is necessary. Other management decisions are left up to the discretion of the care team. Adherence to the treatment protocol will be required for the patients in the operating room, intensive care unit and postoperatively until discharge from the hospital.

Before surgery, the patient will be asked to respond to a quality-of-life questionnaire. Follow up phone calls will be made by Study personnel at 1 and 3 months after surgery to ask the same questions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: January 3, 2019
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Age less than 18 years

• Congenital procedures

• Emergencies

• descending thoracic aortic aneurysm repairs

• Left or right ventricular assist devices

• Left ventricular aneurysm resections

• Heart or lung transplantation

• Those unable to receive blood for religious reasons

Related Conditions & MeSH terms

• Anemia

Intervention

Procedure:
• Blood transfusion at hematocrit value less than 24%
transfusion
• Blood transfusion at hematocrit value less than 28%
transfusion

Locations

Country	Name	City	State
India	S.A.L. Hospital and Medical Institute	Ahmedabad	Thaltej,
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Composite of In-hospital Postoperative Morbidity and Mortality	The composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation [>24 hours]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia).	After surgery until hosptal discharge
Secondary	Length of ICU Stays		After surgery until discharged from ICU
Secondary	Length of Hospital Stay		After surgery until hospital discharge
Secondary	Number of Blood Transfusion		From induction to the end of sugery
Secondary	Prolonged Postoperative Ventilation	On ventilation >24 hours after surgery	After surgeyr until hospital discharge
Secondary	Postoperative Atrial Fibrillation		After surgery until hospital discharge