Extracorporeal Membrane Oxygenation ComplicationPhase 4BIV-ECMO2NCT03965208
Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation
A Phase 4 study testing Bivalirudin and Unfractionated heparin in people with Extracorporeal Membrane Oxygenation Complication and Anticoagulants, run by Legacy Health System at 1 site in United States.
Trial summary
This study will evaluate heparin as compared to bivalirudin for systemic anticoagulation in adult patients that require extracorporeal membrane oxygenation (ECMO). Half of the participants will receive heparin and half will receive bivalirudin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, 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
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2019to 31 Dec 2020
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Require ECMO and systemic anticoagulation as determined by the primary treating physician
- Require anticoagulation to target an activated partial thromboplastin time (aPTT) of 40-60 seconds or 60-80 seconds
Who cannot join
- Prior inclusion in this study
- Patients with known or suspected heparin induced thrombocytopenia
- Systemic anticoagulation at Legacy for ≥ 24 hours during ECMO immediately prior to study enrollment
- Allergy to heparin or related products or bivalirudin
- Known anti-thrombin deficiency
- Selection of a non-standard aPTT target range
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Legacy Health System
Portland, Oregon, 97123
Joseph Deng, MD, 503-413-2000, jdeng@lhs.org
Kyle Kojiro, PharmD, 503-413-2000, kkojiro@lhs.org
About this study
Official title: Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation: an Open Label, Parallel Group Randomized Pilot Study (BIV-ECMO2)
This study will evaluate heparin as compared to bivalirudin for systemic anticoagulation in adult patients that require extracorporeal membrane oxygenation (ECMO). Half of the participants will receive heparin and half will receive bivalirudin.
Read the detailed description
The investigators will randomly assign 34 adult patients requiring ECMO to receive bivalirudin or unfractionated heparin in a 1:1 fashion. There will be 17 patients in each group for a total of 34 patients.
Unfractionated heparin binds to antithrombin thereby causing an anticoagulant effect while bivalirudin binds directly to thrombin. Use of unfractionated heparin in this population is problematic due to reliance on adequate levels of circulating antithrombin, complex pharmacokinetics, and variable clearance. Bivalirudin avoids many of these difficulties.
- Being tested
- Bivalirudin, Unfractionated heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Also called Angiomax
titrated continuous infusion
Unfractionated heparinDrug
titrated continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Unfractionated heparin | Active comparator | Patients randomized to this group will receive anticoagulation with unfractionated heparin Receives: Drug: Unfractionated heparin |
| Bivalirudin | Experimental | Patients randomized to this group 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 in the target anticoagulation range
activated partial thromboplastin time
Measured: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Secondary outcomes (3)
Major bleeding events
Measured: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Major clinical thrombotic events
Measured: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Duration of oxygenator use
Measured: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start23 May 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Pacific University
- Responsible party
- Principal investigator, R. Brigg Turner, Legacy Health System
- Investigators
- R Brigg Turner, PharmD, Principal investigator, Pacific University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965208
- Sponsor's protocol ID
- 1665-2019
- Acronym
- BIV-ECMO2
- Status last verified
- May 2019
- First submitted
- 23 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation: an Open Label, Parallel Group Randomized Pilot Study (BIV-ECMO2)
- ClinicalTrials.gov ID
- NCT03965208
- Acronym / sponsor ID
- BIV-ECMO2 / 1665-2019
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Collaborators
- Pacific University
- Study start
- 23 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 May 2019 (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.
This study will evaluate heparin as compared to bivalirudin for systemic anticoagulation in adult patients that require extracorporeal membrane oxygenation (ECMO). Half of the participants will receive heparin and half will receive bivalirudin.
Detailed description
The investigators will randomly assign 34 adult patients requiring ECMO to receive bivalirudin or unfractionated heparin in a 1:1 fashion. There will be 17 patients in each group for a total of 34 patients.
Unfractionated heparin binds to antithrombin thereby causing an anticoagulant effect while bivalirudin binds directly to thrombin. Use of unfractionated heparin in this population is problematic due to reliance on adequate levels of circulating antithrombin, complex pharmacokinetics, and variable clearance. Bivalirudin avoids many of these difficulties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unfractionated heparin | Active comparator | Drug: Unfractionated heparinPatients randomized to this group will receive anticoagulation with unfractionated heparin |
| Bivalirudin | Experimental | Drug: BivalirudinPatients randomized to this group will receive anticoagulation with bivalirudin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Require ECMO and systemic anticoagulation as determined by the primary treating physician
- Require anticoagulation to target an activated partial thromboplastin time (aPTT) of 40-60 seconds or 60-80 seconds
Key exclusion criteria (6 listed)
- Prior inclusion in this study
- Patients with known or suspected heparin induced thrombocytopenia
- Systemic anticoagulation at Legacy for ≥ 24 hours during ECMO immediately prior to study enrollment
- Allergy to heparin or related products or bivalirudin
- Known anti-thrombin deficiency
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 |
|---|---|---|
| BivalirudinAlso: Angiomaxtitrated continuous infusion | Drug | Bivalirudin |
| Unfractionated heparintitrated continuous infusion | Drug | Unfractionated heparin |
Primary outcome
Percentage of time in the target anticoagulation range
Time frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
activated partial thromboplastin time
3 secondary outcomes
Major bleeding events
Time frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Major clinical thrombotic events
Time frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Duration of oxygenator use
Time frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: No
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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.
R Brigg Turner, PharmD principal investigator
Pacific University
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 Anticoagulants, run by Legacy Health System 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: status not confirmed, as of the sponsor's last update on 28 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R Brigg Turner, PharmD (503-352-7288, brigg.turner@pacificu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time in the target anticoagulation range (time frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks). 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 28 May 2019.