Blood Conservation in Cardiac Surgery

NCT01463345 | Withdrawn DMC

• 1 other identifier: Pro00001949
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to examine the safety of two different hemoglobin (Hgb)-based transfusion triggers in patients post cardiac surgery.

Conditions

Transfusion Reactions; Post Cardiac Surgery

Keywords

Blood conservation; Transfusion; Hemoglobin trigger; Transfusion trigger; Cardiac surgery; Transfusion triggers post cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Safety of the lower hemoglobin transfusion trigger of 7.5 g/dl against the higher hemoglobin transfusion trigger of 9.0 g/dl.

  This outcome measure is a simultaneous assessment of the multiple end points duration of pressor use, symptomatic anemia, anemia-associated hypotension within 48 hours post surgery and Hgb recovery by day 4 post-surgery.

  The assessment will last untill day 4 post surgery

Secondary Outcomes (1)

• Rate of incidence of transfusion related complications between the two randomizations arms.

  This will be compared during the hospital stay, untill 30 days after discharge.

Study Arms (2)

Conservative Transfusion Arm

EXPERIMENTAL

Subjects in the conservative transfusion arm will receive transfusion only when their hemoglobin levels reach 7.5 g/dl.

Other: Blood transfusion

Liberal Transfusion Arm

ACTIVE COMPARATOR

Subjects in the liberal transfusion arm will receive transfusion only when their hemoglobin levels reach 9.0 g/dl.

Other: Blood transfusion

Interventions

Blood transfusion OTHER

Conservative transfusion arm: Subjects randomized to the conservative transfusion arm will receive transfusions of PRBCs post-surgery only when their Hgb level measures \< 7.5 g/dl. Blood products should be given to maintain Hgb levels \>7.5 g/dl.

Conservative Transfusion Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects scheduled to undergo any of the following cardiac surgeries as part of their routine medical care:
• CABG
• AVR
• MVR
• MV Repair
• CABG/AVR
• CABG/MVR
• CABG/MV Repair
• Thoracic Aneurysm Repair ± any concomitant cardiac procedure (valve, CABG, etc.)
• Subjects must be \> 18 years of age
• No prior history of cardiac surgery.
• Able and willing to give informed consent

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from participation in this study:
• Prior history of cardiac surgery
• Patients who do not have sufficient time prior to surgery to give proper informed consent (i.e.: immediate, emergency surgery)
• Patients who are younger than 18 years of age
• Prior history of
• bleeding disorders
• symptomatic anemia (i.e. persistent tachycardia, orthostatic hypotension, persistent pressor requirement)
• hereditary/acquired coagulopathy
• platelet defects (e.g.: disseminated intravascular coagulation (DIC), hemophilia, Henoch-Schönlein purpura, hereditary hemorrhagic telangiectasia, thrombocytopenia (ITP, TTP), thrombophilia, Von Willebrand's disease)
• History of leukemia or any other blood related malignancy
• History of liver failure
• Current, or history of, pre-existing medical condition other than current cardiac condition, which in the opinion of the investigator, would place the subject at risk or have the potential to confound interpretation of the study results
• Participation in another clinical trial
• Lack of capacity to give informed consent.

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Rutgers, The State University of New Jersey: collaborator

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Transfusion Reaction

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Leonard Lee, M.D.

  Dr Lee is leaving Hackensack University Medical Center on June 30th, 2012. Effective July 1st, 2012 he will assume his new role as the Chief of Cardiothoracic Surgery Division at the University OF Medicine & Dentistry OFNew Jersey-Robert Wood Johnson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 1, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

US (1)