Transfusion Strategies in Pediatric Cardiothoracic Surgery

Congenital Heart Disease Clinical Trial

Official title:

A Prospective, Randomized, Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350220
• Other study ID #: 12408
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2006
• Last updated: May 29, 2015
• Start date: July 2006
• Est. completion date: September 2009

Study information

• Verified date: May 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 7 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital

Intervention

Other:
• transfusion strategy
For the High Hb group; transfusions will be given to keep the Hb >13.0 g/dl
• Low Hb transfusion group
RBCs will not be transfused unless the Hb < 9.0 g/dl

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Arterial Lactate Level	Mean arterial lactate for the first 48 hours post-op.	48 hours	No
Primary	Peak Arterial Lactate Level	Peak arterial lactate level for the 48 hour post-op study period.	48 hours	No
Secondary	Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.		3 days	No
Secondary	Length of Mechanical Ventilation		3 days	No
Secondary	Length of Oxygen Use		3 days	No
Secondary	Length of Vasoactive Agent Administration		3 days	No
Secondary	Volume of Blood Transfused		3 days	No
Secondary	Mortality Before Hospital Discharge		30 days	No