Extracorporeal Membrane Oxygenation ComplicationPhase 4NCT03318393
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
A Phase 4 study testing Bivalirudin and Unfractionated heparin in people with Extracorporeal Membrane Oxygenation Complication and Pediatric ALL, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Pediatric ALL, Anticoagulants
- What is being tested?
- Bivalirudin and Unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2018to 8 Oct 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1 day to less than 18 years
- Cared for in the pediatric intensive care unit or pediatric cardiac intensive care unit
- receiving venovenous or venoarterial ECMO
Who cannot join
- Patients with known or suspected heparin induced thrombocytopenia prior to consent
- Patients with hepatic failure defined as coagulopathy with elevated transaminases more than three times normal values
- Patients with plan to decannulate from ECMO within 48 hours
- Known or suspected pregnant women
- Previous enrollment in this study
- Primary language spoken that is not English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.
Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.
Read the detailed description
The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.
The investigators hypothesize that neonatal and pediatric ECMO patients receiving bivalirudin will spend more time at goal anticoagulation and will experience less hemorrhagic and thrombotic complications when compared to patients receiving unfractionated heparin. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin. The investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic complications in patients receiving bivalirudin during ECMO.
- Being tested
- Bivalirudin, Unfractionated heparin
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Continuous infusion
Unfractionated heparinDrug
Continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Unfractionated heparin group | Active comparator | Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Receives: Drug: Unfractionated heparin |
| Bivalirudin group | Experimental | Patients randomized to this arm will receive anticoagulation with bivalirudin Receives: Drug: Bivalirudin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time Spent at Goal Anticoagulation
Measured: through study completion, an average of 1-2 weeks
Secondary outcomes (1)
Number of Participants With One or More Major Bleeding Events
Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding
Measured: through study completion, an average of 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start25 Mar 2018
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lakshmi Raman, University of Texas Southwestern Medical Center
- Investigators
- Ali McMichael, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318393
- Sponsor's protocol ID
- 072017-045
- Status last verified
- Dec 2022
- First submitted
- 4 Oct 2017
- Last updated
- 31 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McMichael A, Weller J, Li X, Hatton L, Zia A, Raman L. Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation. Pediatr Crit Care Med. 2025 Jan 1;26(1):e86-e94. doi: 10.1097/PCC.0000000000003642. Epub 2024 Nov 25.
PubMed 39585174
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT03318393
- Acronym / sponsor ID
- 072017-045
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Posted 31 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.
Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.
Detailed description
The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.
The investigators hypothesize that neonatal and pediatric ECMO patients receiving bivalirudin will spend more time at goal anticoagulation and will experience less hemorrhagic and thrombotic complications when compared to patients receiving unfractionated heparin. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin. The investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic complications in patients receiving bivalirudin during ECMO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unfractionated heparin group | Active comparator | Drug: Unfractionated heparinPatients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. |
| Bivalirudin group | Experimental | Drug: BivalirudinPatients randomized to this arm will receive anticoagulation with bivalirudin |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 1 day to less than 18 years
- Cared for in the pediatric intensive care unit or pediatric cardiac intensive care unit
- receiving venovenous or venoarterial ECMO
Key exclusion criteria (6 listed)
- Patients with known or suspected heparin induced thrombocytopenia prior to consent
- Patients with hepatic failure defined as coagulopathy with elevated transaminases more than three times normal values
- Patients with plan to decannulate from ECMO within 48 hours
- Known or suspected pregnant women
- Previous enrollment in this study
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 |
|---|---|---|
| BivalirudinContinuous infusion | Drug | Bivalirudin group |
| Unfractionated heparinContinuous infusion | Drug | Unfractionated heparin group |
Primary outcome
Percentage of Time Spent at Goal Anticoagulation
Time frame: through study completion, an average of 1-2 weeks
1 secondary outcome
Number of Participants With One or More Major Bleeding Events
Time frame: through study completion, an average of 1-2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39585174McMichael A, Weller J, Li X, Hatton L, Zia A, Raman L. Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation. Pediatr Crit Care Med. 2025 Jan 1;26(1):e86-e94. doi: 10.1097/PCC.0000000000003642. Epub 2024 Nov 25.
- Individual participant dataSharing planned: Undecided
Related trials for Extracorporeal Membrane Oxygenation Complication
Not yet recruitingObservational study
Diagnosis of ECMO Cannula Infection: Prospective Comparison of Sampling Methods
ECMO Cannula Infection, Extracorporeal Membrane Oxygenation Complication
Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Recruiting
ECMO ABI Detection With Hyperfine
Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication
RecruitingPhase 1
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
Cardiogenic Shock, Extracorporeal Membrane Oxygenation
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.
Ali McMichael, MD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalirudin and Unfractionated heparin in people with Extracorporeal Membrane Oxygenation Complication and Pediatric ALL, run by University of Texas Southwestern Medical Center 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 31 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Time Spent at Goal Anticoagulation (time frame: through study completion, an average of 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318393, which also lists 1 linked publication.
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 31 Jan 2023.