NCT00350220

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 25, 2010

Completed
Last Updated

June 26, 2015

Status Verified

May 1, 2015

Enrollment Period

3.2 years

First QC Date

July 5, 2006

Results QC Date

January 19, 2010

Last Update Submit

May 29, 2015

Conditions

Congenital Heart Disease

Keywords

Single ventricleBidirectional GlennFontanCongenital cardiac diseaseRed blood cell transfusionoxygen utilizationlactate levelhemoglobin level

Outcome Measures

Primary Outcomes (2)

  • Mean Arterial Lactate Level

    Mean arterial lactate for the first 48 hours post-op.

    48 hours

  • Peak Arterial Lactate Level

    Peak arterial lactate level for the 48 hour post-op study period.

    48 hours

Secondary Outcomes (6)

  • Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.

    3 days

  • Length of Mechanical Ventilation

    3 days

  • Length of Oxygen Use

    3 days

  • Length of Vasoactive Agent Administration

    3 days

  • Volume of Blood Transfused

    3 days

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

Interventions

transfusion strategyOTHER

For the High Hb group; transfusions will be given to keep the Hb \>13.0 g/dl

1
Low Hb transfusion groupOTHER

RBCs will not be transfused unless the Hb \< 9.0 g/dl

2

Eligibility Criteria

Age4 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • presence of known bleeding disorder
  • presence of known coagulopathy
  • age \< 4 months
  • age \> 7 years
  • non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalUniventricular Heart

Interventions

Bloodless Medical and Surgical Procedures

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsSurgical Procedures, OperativeHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

There were no limitations to this study. There was 100% compliance with study procedures. There were no adverse events.

Results Point of Contact

Title
Jill M. Cholette MD
Organization
University of Rochester Medical Center
Jill_Cholette@urmc.rochester.edu
585-275-0189

Study Officials

  • Jill M Cholette, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 10, 2006

Study Start

July 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 26, 2015

Results First Posted

February 25, 2010

Record last verified: 2015-05

Locations

US(1)