ECMONCT04478136
Can Blood Panels Provide Early Warning of Bleeding in Patients on ECMO?
An observational study of ECMO and Bleeding, run by Montefiore Medical Center.
Trial summary
This is a prospective, observational study of 60 adult patients anticoagulated with bivalirudin for extracorporeal membrane oxygenation (ECMO). The study aims to identify the most precise early warning blood test or panel of blood tests to predict bleeding in patients on bivalirudin/ECMO. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Blood test of factor levels
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Jun 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population in this prospective cohort study will include sixty (60) adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or respiratory failure.
Who may be able to join
- adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or respiratory failure. Surgical and non-surgical patients will be included.
Who cannot join
- known pre-existing bleeding disorder (due to a factor deficiency that requires factor replacement, or platelet disorder), or a creatinine > 2.0.
About this study
This is a prospective, observational study of 60 adult patients anticoagulated with bivalirudin for extracorporeal membrane oxygenation (ECMO). The study aims to identify the most precise early warning blood test or panel of blood tests to predict bleeding in patients on bivalirudin/ECMO. The project will involve comparing currently used blood tests with an extended panel of coagulation and metabolic blood tests with the aim of early warning of impending bleeding to allow intervention in the form of adjusted bivalirudin dose, modification of other risk factors, or transfusion with hemostatic products targeted to documented coagulation test abnormalities.
- Being tested
- Blood test of factor levels
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test of factor levelsDiagnostic test
Blood draw from central line to check coagulation factors
| Study group | Role | What they receive |
|---|---|---|
| Major bleeders (MB) | Additional blood to be drawn from patients on ECMO who have a major bleeding event. Receives: Diagnostic Test: Blood test of factor levels | |
| Non-major bleeders (NMB) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups.
To determine if changes over time in an extended blood panel (EBP) and metabolic panel (MP) could provide early warning of impending bleeding in patients on ECMO.
The extended blood panel includes: Dilute thrombin time (DTT), Factor XIII, Factor VIII, Factor IX, and Von Willebrand Disease (VWD) panel, and Factor XI, Factor X, Factor VII, Factor V, Factor II, protein C, protein S, thromboelastogram (TEG), and TEG-platelet mapping).
Measured: Up to 2 weeks
Secondary outcomes (2)
Number of participants designated as major bleeders (MB)
Measured: Up to 2 weeks
Number of participants designated as non-major bleeders (NMB)
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Why it stopped: This protocol was never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECMOStudies of the same condition, open and under way.
- More trials run by Montefiore 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiri Mackersey, MBChB, Principal investigator, Albert Einstein College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478136
- Sponsor's protocol ID
- 2019-10472
- Other IDs
- 2019
- Status last verified
- Apr 2022
- First submitted
- 15 Jul 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Blood Panels Provide Early Warning of Bleeding in Patients on ECMO?
- ClinicalTrials.gov ID
- NCT04478136
- Acronym / sponsor ID
- 2019-10472
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This protocol was never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 20 Jul 2020 (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 is a prospective, observational study of 60 adult patients anticoagulated with bivalirudin for extracorporeal membrane oxygenation (ECMO). The study aims to identify the most precise early warning blood test or panel of blood tests to predict bleeding in patients on bivalirudin/ECMO. The project will involve comparing currently used blood tests with an extended panel of coagulation and metabolic blood tests with the aim of early warning of impending bleeding to allow intervention in the form of adjusted bivalirudin dose, modification of other risk factors, or transfusion with hemostatic products targeted to documented coagulation test abnormalities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major bleeders (MB) | – | Diagnostic Test: Blood test of factor levelsAdditional blood to be drawn from patients on ECMO who have a major bleeding event. |
| Non-major bleeders (NMB) | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population in this prospective cohort study will include sixty (60) adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or respiratory failure.
Key inclusion criteria (1 listed)
- adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or respiratory failure. Surgical and non-surgical patients will be included.
Key exclusion criteria (1 listed)
- known pre-existing bleeding disorder (due to a factor deficiency that requires factor replacement, or platelet disorder), or a creatinine > 2.0.
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 |
|---|---|---|
| Blood test of factor levelsBlood draw from central line to check coagulation factors | Diagnostic test | Major bleeders (MB) |
Primary outcome
Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups.
Time frame: Up to 2 weeks
To determine if changes over time in an extended blood panel (EBP) and metabolic panel (MP) could provide early warning of impending bleeding in patients on ECMO. The extended blood panel includes: Dilute thrombin time (DTT), Factor XIII, Factor VIII, Factor IX, and Von Willebrand Disease (VWD) panel, and Factor XI, Factor X, Factor VII, Factor V, Factor II, protein C, protein S, thromboelastogram (TEG), and TEG-platelet mapping).
2 secondary outcomes
Number of participants designated as major bleeders (MB)
Time frame: Up to 2 weeks
Number of participants designated as non-major bleeders (NMB)
Time frame: Up to 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for ECMO
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach
VA-ECMO
Not yet recruitingObservational study
Diagnosis of ECMO Cannula Infection: Prospective Comparison of Sampling Methods
ECMO Cannula Infection, Extracorporeal Membrane Oxygenation Complication
RecruitingObservational study
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Not yet recruitingPhase 1/2
PACE: Prostacyclin AntiCoagulation in ECMO
ECMO
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.
Kiri Mackersey, MBChB principal investigator
Albert Einstein College
Questions about this trial
What is this clinical trial studying?
An observational study of ECMO and Bleeding, run by Montefiore Medical Center.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups. (time frame: Up to 2 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 Apr 2022.