- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03472768
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Robert Hyslop, RN
- Email: robert.hyslop@childrenscolorado.org
Study Locations
-
-
Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado and the University of Colorado School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ECMO group - Thirty critically-ill children (age newborn to 18 years) who are intubated and supported by ECMO. We will target enrollment of 15 subjects less than 12 months of age (with at least 10 subjects enrolled less than 6 months of age) and 15 subjects over 12 months of age. These targets are set to address the secondary aim in the context of normal adult-level haptoglobin concentrations reportedly achieved by 6-12 months of age.
Age-matched control group - Sixty critically-ill children (age newborn to 18 years) who are intubated with acute respiratory failure due to any cause and not supported by ECMO. Two control subjects will be enrolled for every 1 experimental ECMO subject. Age-matching will be performed by the following age groups:
- Neonates 37-40 weeks gestation
- Neonates 40-42 weeks gestation
- Neonates 42-44 weeks gestation
- Neonates 44-46 weeks gestation
- Neonates 46-48 weeks gestation
- Infants 2-4 months of age
- Infants 4-6 months of age
- Infants 6-12 months of age
- Children 1-4 years of age
- Children 4-8 years of age
- Children 8-12 years of age
- Children 12-18 years of age
Age-matched control subjects will proceed through the 3 total blood sample collections even if endotracheal extubation occurs within the 3 days of study participation. Age-matching is intended to collect a sample population comparable to the ECMO subject population. We will not match to gender.
Exclusion Criteria (both groups, ECMO and age-matched controls):
- Personal or family history of thrombotic, hemorrhagic, or hemolytic disease.
- Personal history of hematologic malignancy.
- Premature neonates less than 37-weeks gestation and/or less than 2 kg in weight.
- Infection will not be an excluding factor for either subject group.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ECMO-supported group
Thirty critically-ill children (age newborn to 18 years) who are intubated and supported by ECMO.
Normal adult-level haptoglobin concentrations are achieved by 6-12 months of age.
We will target enrollment of 15 subjects less than 12 months of age and 15 subjects over 12 months of age
|
N/A, comparison of haptoglobin concentration between groups
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Age-matched group with respiratory failure
Sixty critically-ill children (age newborn to 18 years) who are intubated with acute respiratory failure due to any cause and not supported by ECMO.
Two control subjects will be enrolled for every 1 experimental ECMO subject.
|
N/A, comparison of haptoglobin concentration between groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterize the relationship between plasma haptoglobin and free hemoglobin levels in children supported by ECMO.
Time Frame: Daily for 7 days
|
Serum Haptoglobin (Hp) will be measured daily for 7 days in subjects supported by Extracorporeal Membrane Oxygenation (ECMO).
In particular, the relative deficiency of Hp production in neonates will be associated with higher Hp levels.
In older children with normal and adequate Hp production, there will be consistently low fHgb concentrations regardless of the other risk factors for hemolysis during ECMO support.
|
Daily for 7 days
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Characterize the relationship between plasma haptoglobin and free hemoglobin levels in children supported by ECMO.
Time Frame: 7 days
|
Plasma free hemoglobin (fHgb) concentrations will be extracted from the medical record.
Periods of high fHgb associated with hemolysis during ECMO support will be associated with deficiency of Hp at that time.
|
7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterize the deficiency of plasma haptoglobin at birth.
Time Frame: Daily for 3 days
|
Serum Hp and fHgb will be measured daily for 3 days in age-matched control subjects to characterize levels in a cohort of critically-ill children comparable to the ECMO cohort.
Neonates and children with non-ECMO supported critical illness will have negligible risk for hemolysis and, thus, low plasma fHgb.
Serum Hp concentrations will be similar to the previously-characterized norms in healthy subjects (eg.
deficient at birth until 6-12 months of age).
|
Daily for 3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Kim, MD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-2058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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