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Transfusion Strategies in Pediatric Cardiothoracic Surgery

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ClinicalTrials.gov Identifier: NCT00350220
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : February 25, 2010
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
jill cholette, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Congenital Heart Disease
Interventions Other: transfusion strategy
Other: Low Hb transfusion group
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Hemoglobin (Liberal) Group Low Hb (Restrictive) Group
Hide Arm/Group Description High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion. Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title High Hemoglobin (Liberal) Group Low Hb (Restrictive) Group Total
Hide Arm/Group Description High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion. Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
30
 100.0%
30
 100.0%
60
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: subjects under 8 years of age included
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
2.75  (1.9) 2.25  (1.8) 2.5  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
13
  43.3%
13
  43.3%
26
  43.3%
Male
17
  56.7%
17
  56.7%
34
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Mean Arterial Lactate Level
Hide Description Mean arterial lactate for the first 48 hours post-op.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Hemoglobin (Liberal) Group Low Hb (Restrictive) Group
Hide Arm/Group Description:
High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.4  (0.4) 1.4  (0.5)
2.Primary Outcome
Title Peak Arterial Lactate Level
Hide Description Peak arterial lactate level for the 48 hour post-op study period.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Hemoglobin (Liberal) Group Low Hb (Restrictive) Group
Hide Arm/Group Description:
High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: mmol/l
3.2  (1.3) 3.1  (1.5)
3.Secondary Outcome
Title Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.
Hide Description [Not Specified]
Time Frame 3 days
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Length of Mechanical Ventilation
Hide Description [Not Specified]
Time Frame 3 days
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Length of Oxygen Use
Hide Description [Not Specified]
Time Frame 3 days
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Length of Vasoactive Agent Administration
Hide Description [Not Specified]
Time Frame 3 days
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Volume of Blood Transfused
Hide Description [Not Specified]
Time Frame 3 days
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Mortality Before Hospital Discharge
Hide Description [Not Specified]
Time Frame 30 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Hemoglobin (Liberal) Group Low Hb (Restrictive) Group
Hide Arm/Group Description High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion. Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
All-Cause Mortality
High Hemoglobin (Liberal) Group Low Hb (Restrictive) Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
High Hemoglobin (Liberal) Group Low Hb (Restrictive) Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Hemoglobin (Liberal) Group Low Hb (Restrictive) Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
There were no limitations to this study. There was 100% compliance with study procedures. There were no adverse events.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jill M. Cholette MD
Organization: University of Rochester Medical Center
Phone: 585-275-0189
EMail: Jill_Cholette@urmc.rochester.edu
Layout table for additonal information
Responsible Party: jill cholette, University of Rochester
ClinicalTrials.gov Identifier: NCT00350220    
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