Respiratory FailureNCT03472768
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
An observational study of Respiratory Failure, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Newborns and children with life-threatening heart and lung failure may require support with ECMO (extracorporeal membrane oxygenation). With ECMO, oxygen and carbon dioxide are exchanged and circulated throughout the body even if the heart is unable to do so. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Plasma Haptoglobin Concentration
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2018to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Critically-ill children with respiratory failure requiring mechanical circulatory and/or respiratory support.
Who may be able to join
- 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
Show all 20Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado and the University of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
Newborns and children with life-threatening heart and lung failure may require support with ECMO (extracorporeal membrane oxygenation). With ECMO, oxygen and carbon dioxide are exchanged and circulated throughout the body even if the heart is unable to do so. Unfortunately, ECMO can cause breakdown of the red blood cells (known as hemolysis). For unclear reasons, newborns are at particularly high risk of hemolysis while being supported by ECMO. The amount of hemolysis is measured with concentrations of a breakdown product from red blood cells known as free hemoglobin. One possible reason for high free hemoglobin levels in newborns on ECMO could be related to another blood protein called haptoglobin. Haptoglobin is known to help in clearing free hemoglobin through the kidneys into the urine. However, haptoglobin levels in newborns can be very low and increases slowly during the first few months of life. Free hemoglobin may be inappropriately high in newborns supported by ECMO because of low levels of haptoglobin. The purpose of this study is to characterize haptoglobin, free hemoglobin, and hemolysis in newborns and children supported by ECMO and compare those values to age-matched newborns and children not on ECMO.
- Conditions
- Respiratory Failure
- Being tested
- Plasma Haptoglobin Concentration
- Keywords
- ECMO
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma Haptoglobin ConcentrationDiagnostic test
N/A, comparison of haptoglobin concentration between groups
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Plasma Haptoglobin Concentration | |
| 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. Receives: Diagnostic Test: Plasma Haptoglobin Concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the relationship between plasma haptoglobin and free hemoglobin levels in children supported by ECMO.
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.
Measured: Daily for 7 days
Characterize the relationship between plasma haptoglobin and free hemoglobin levels in children supported by ECMO.
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.
Measured: 7 days
Secondary outcomes (1)
Characterize the deficiency of plasma haptoglobin at birth.
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).
Measured: Daily for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start25 Sep 2018
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Kim, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472768
- Sponsor's protocol ID
- 16-2058
- Status last verified
- Dec 2023
- First submitted
- 2 Feb 2018
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
- ClinicalTrials.gov ID
- NCT03472768
- Acronym / sponsor ID
- 16-2058
- Conditions
- Respiratory Failure
- Keywords
- ECMO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Newborns and children with life-threatening heart and lung failure may require support with ECMO (extracorporeal membrane oxygenation). With ECMO, oxygen and carbon dioxide are exchanged and circulated throughout the body even if the heart is unable to do so. Unfortunately, ECMO can cause breakdown of the red blood cells (known as hemolysis). For unclear reasons, newborns are at particularly high risk of hemolysis while being supported by ECMO. The amount of hemolysis is measured with concentrations of a breakdown product from red blood cells known as free hemoglobin. One possible reason for high free hemoglobin levels in newborns on ECMO could be related to another blood protein called haptoglobin. Haptoglobin is known to help in clearing free hemoglobin through the kidneys into the urine. However, haptoglobin levels in newborns can be very low and increases slowly during the first few months of life. Free hemoglobin may be inappropriately high in newborns supported by ECMO because of low levels of haptoglobin. The purpose of this study is to characterize haptoglobin, free hemoglobin, and hemolysis in newborns and children supported by ECMO and compare those values to age-matched newborns and children not on ECMO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO-supported group | – | Diagnostic Test: Plasma Haptoglobin ConcentrationThirty 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 |
| Age-matched group with respiratory failure | – | Diagnostic Test: Plasma Haptoglobin ConcentrationSixty 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Critically-ill children with respiratory failure requiring mechanical circulatory and/or respiratory support.
Key inclusion criteria (20 listed)
- 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:
- 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.
- Personal or family history of thrombotic, hemorrhagic, or hemolytic disease.
- Personal history of hematologic malignancy.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma Haptoglobin ConcentrationN/A, comparison of haptoglobin concentration between groups | Diagnostic test | Age-matched group with respiratory failure, ECMO-supported group |
Primary outcome
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.
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.
1 secondary outcome
Characterize the deficiency of plasma haptoglobin at birth.
Time frame: Daily for 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kim, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the relationship between plasma haptoglobin and free hemoglobin levels in children supported by ECMO. (time frame: Daily for 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.