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Transfusion Strategies in Pediatric Cardiothoracic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350220
First Posted: July 10, 2006
Last Update Posted: June 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
jill cholette, University of Rochester
  Purpose
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects. These children often receive red blood cell transfusions after surgery, but what the best hemoglobin level is for them remains unknown.

Condition Intervention Phase
Congenital Heart Disease Other: transfusion strategy Other: Low Hb transfusion group Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection.

Resource links provided by NLM:


Further study details as provided by jill cholette, University of Rochester:

Primary Outcome Measures:
  • Mean Arterial Lactate Level [ Time Frame: 48 hours ]
    Mean arterial lactate for the first 48 hours post-op.

  • Peak Arterial Lactate Level [ Time Frame: 48 hours ]
    Peak arterial lactate level for the 48 hour post-op study period.


Secondary Outcome Measures:
  • Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period. [ Time Frame: 3 days ]
  • Length of Mechanical Ventilation [ Time Frame: 3 days ]
  • Length of Oxygen Use [ Time Frame: 3 days ]
  • Length of Vasoactive Agent Administration [ Time Frame: 3 days ]
  • Volume of Blood Transfused [ Time Frame: 3 days ]
  • Mortality Before Hospital Discharge [ Time Frame: 30 days ]

Enrollment: 60
Study Start Date: July 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
High Hemoglobin group; goal Hb >13g/dl. 10cc/kg RBCs are transfused for any hemoglobin value under 13g/dl regardless whether clinical indication for transfusion exists.
Other: transfusion strategy
For the High Hb group; transfusions will be given to keep the Hb >13.0 g/dl
Active Comparator: 2
Low Hb transfusion group; goal to not transfuse unless the Hb <9.0 g/dl. 10cc/kg RBCs are transfused only if the Hemoglobin is under 9.0g/dl and clinical indications for transfusion exist.
Other: Low Hb transfusion group
RBCs will not be transfused unless the Hb < 9.0 g/dl

Detailed Description:

Objective: To compare mean post-operative arterial lactate levels, oxygen utilization, and outcome measures in pediatric patients undergoing cavopulmonary connection managed with two different red blood cell transfusion strategies.

Methods: We propose a prospective, randomized clinical trial of sixty-six pediatric patients with cyanotic, complex congenital cardiac disease undergoing cavopulmonary connection as their operative repair. Thirty-three patients will be randomly assigned to a low Hb strategy of transfusion, in which red cells are transfused if the hemoglobin concentration falls below 9.0 g/dL, and hemoglobin concentrations are maintained about 8.5 g/dL. Thirty-three additional patients will be randomly assigned to the high Hb transfusion strategy, where red cells are transfused if the hemoglobin concentration falls below 13.0 g/dL, and hemoglobin concentrations are maintained about 12.5 g/dL. The primary endpoint will be comparison of mean arterial lactate levels from 8 to 72 hours post-operatively. The secondary endpoints will be oxygen utilization reflected by the arterio-venous oxygen difference (AV-difference) and arterio-cerebral oxygen difference (AC-difference). Measures of oxygen utilization will be derived from arterial oxygen saturation (SaO2), mixed venous oxygen saturation (SvO2), and cerebral oxygen saturation (ScO2) collected at various time points throughout the study. Tertiary outcome measures will be length of mechanical ventilation, length of oxygen use and of vasoactive agent administration, length pediatric cardiac intensive care unit (PCICU) admission, volume of blood transfused, and mortality. Data from each group will be compared using analysis of variance to assess for the presence of a difference between the two transfusion strategies. If a significant difference between the two groups exists, T-tests will be performed to compare data points between each group to assess for a significant difference.

Hypothesis: A more restrictive (low Hb) strategy of red cell transfusion will be as effective as, and possibly superior to, the historical (high Hb) approach. Allowing a lower Hb concentration will decrease RBC donor exposure and may decrease the known complications of RBC transfusions. We postulate that no significant difference will exist between the two transfusion groups in regards to hemodynamic and cardiopulmonary status (as evidenced by mean lactate levels) and oxygen utilization.

  Eligibility

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Ages Eligible for Study:   4 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 4 months to 6.99 years of age
  • surgical candidates for cavopulmonary connection
  • English speaking

Exclusion Criteria:

  • presence of known bleeding disorder
  • presence of known coagulopathy
  • age < 4 months
  • age > 7 years
  • non-English speaking
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350220


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jill M Cholette, MD University of Rochester
  More Information

Responsible Party: jill cholette, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00350220     History of Changes
Other Study ID Numbers: 12408
First Submitted: July 5, 2006
First Posted: July 10, 2006
Results First Submitted: January 19, 2010
Results First Posted: February 25, 2010
Last Update Posted: June 26, 2015
Last Verified: May 2015

Keywords provided by jill cholette, University of Rochester:
Single ventricle
Bidirectional Glenn
Fontan
Congenital cardiac disease
Red blood cell transfusion
oxygen utilization
lactate level
hemoglobin level

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases