Skip to main content
OpenTrials
Completed

NCT Number: NCT01484886

Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery

In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Impaired Oxygen Delivery Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children </= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.

Exclusion criteria

  • presence of a known bleeding disorder or coagulopathy.
  • age > 6 months,
  • lack of informed consent.

Treatment and study plan

Red blood cell Transfusion

Other

10cc/kg weight RBC transfusion as needed according to hemoglobin level

Primary outcomes

  1. oxygen utilization derived from the arterio-venous oxygen difference.

    Time frame: 3 days

    Arterial and venous oxygen saturations will be measured every four hours x 48-72 hours and will be used to calculate arterio-venous oxygen content differences.

Secondary outcomes

  1. volume of RBC transfused

    Time frame: 7 days

    The total numbers of RBC transfusions given during the immediate post-op period (1st 7 days) will be compared between groups.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 2, 2011
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.