Bleeding DisorderELMOHNCT04912336
Extracorporeal Life Support and Modification of Hemostasis
An observational study of Bleeding Disorder and Extra Corporeal Life Support, run by University Hospital, Ghent at 6 sites in 2 countries.
Trial summary
To evaluate change in coagulation tests during a 48-h period after initiation VV-ECMO and VA-ECMO. (ECMO= Extra Corporeal Membrane Oxygenator) Assessment of bleeding during Veno-Venous Extracoporeal Membrane Oxygenator (VV-ECMO) and Veno-Arterial Extracoporeal Membrane Oxygenator (VA-ECMO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Disorder, Extra Corporeal Life Support, Thrombosis
- What is being tested?
- Standard coagulation profile, Specific coagulation tests and Bleeding Scores
- How many people
- 43 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 28 May 2021to 30 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * GROUP 1: patients who will be initiated on VV-ECMO within a 12-h period * GROUP 2: patients who will be initiated on VA-ECMO within a 12-h period
Who may be able to join
- GROUP 1: patients who will be initiated on VV-ECMO within a 12-h period
- GROUP 2: patients who will be initiated on VA-ECMO within a 12-h period
- ≥ 18 years
- Signed Informed Consent, signed by subject or authorized representative
Who cannot join
- Expected survival <48-h Known coagulopathy Pregnancy
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Belgium5 sites
Ghent University Hospital
Ghent, 9000
University Hospital Brussels
Jette, 1090
Centre Hospitalier Universitaire Liege
Liège, 4000
CHU Charleroi
Lodelinsart, Henegouwen, 6042
CHU UCL Namur- Godinne
Yvoir, Namen, 5530
About this study
Official title: Extra Corporeal Life Support and Modification of Hemostasis
To evaluate change in coagulation tests during a 48-h period after initiation VV-ECMO and VA-ECMO.
(ECMO= Extra Corporeal Membrane Oxygenator) Assessment of bleeding during Veno-Venous Extracoporeal Membrane Oxygenator (VV-ECMO) and Veno-Arterial Extracoporeal Membrane Oxygenator (VA-ECMO).
Read the detailed description
This is a multi-center, prospective, pilot cohort study, performed in the Intensive Care Units (ICUs) of the Ghent University Hospital, CHU Liège, University Hospital Brussels, and University Hospital Munster.
Each group will contain 20 subjects; in total there will be 40 subjects 2 groups of 20 patients GROUP 1: VV-ECMO n = 20 GROUP 2: VA-ECMO n = 20
- Demographics: age, sex, comorbidities, medication, reason for ECMO therapy
- Simplified Acute Physiology Score (SAPS) 3 at time of ICU admission.
- Components of the Sequential Organ Failure Assessment score daily (based on worst value of each component of the score)
- ECMO characteristics (place of cannulation, type of cannulas, oxygenator, bloodflow, gasflow and pressure registrations)
- Incidence and severity of bleeding, scored according to the GUSTO and BARC scores
- Coagulation profile: At inclusion (before heparine infusion is started), 2h after start of therapy, 24h, and 48h, and at specific moments of clinical suspicion of profound altered hemostasis. We defined a coagulation profile as a set of tests that includes
- prothrombin time (PT), international normalized ratio (INR)
- activated partial thromboplastin time (aPTT) and heparin ratio
- the fibrinogen level
- platelets
- ACT (iACT®, …)
- D-dimer
- ROTEM (extem, intem, heptem) or TEG (Utrecht)
- AT III
- anti Xa
- Temperature daily (H/L) (core)
- Patient characteristics that may influence coagulation or the results of coagulation tests: body weight, Body Mass Index, drugs, C-reactive protein (as a marker for inflammation), Hemoglobin level, LDH, unconjugated bilirubin, (or haptoglobine or plasma free haemoglobin, if tested)
- Heparin dose
- Conditions
- Bleeding Disorder, Extra Corporeal Life Support, Thrombosis
- Being tested
- Standard coagulation profile, Specific coagulation tests, Bleeding Scores
- Medical subject headings
- Hemostatic Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard coagulation profileDiagnostic test
prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount
Specific coagulation testsDiagnostic test
AT III, anti Xa, ACT, ROTEM
Bleeding ScoresOther
Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)
| Study group | Role | What they receive |
|---|---|---|
| VV-ECMO | Patients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator. Receives: Diagnostic Test: Standard coagulation profile; Diagnostic Test: Specific coagulation tests; Other: Bleeding Scores | |
| VA-ECMO | Patients supported because of circulatory failure by Veno-Arterial Extra Corporeal Membrane Oxygenator. Receives: Diagnostic Test: Standard coagulation profile; Diagnostic Test: Specific coagulation tests; Other: Bleeding Scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombocytopenia
Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients
Measured: 48 hours
Secondary outcomes (5)
Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria
incidence of clinical overt bleeding
Measured: 48 hours
Clotting problems
Incidence of deep venous trombosis or emboli or ECMO circuit problems due to clotting
Measured: 48 hours
Need for transfusion
Need for transfusion of packed red blood cells
Measured: 48 hours
Change in visco-elastic testing
ROTEM changes
Measured: At 2 hours, 24 hours, 48 hours
Survival
survival in the ICU, in the hospital, at day 28, day 90, 6months and 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start28 May 2021
- Primary completion16 Jan 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harlinde Peperstraete, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912336
- Sponsor's protocol ID
- BC-07099
- Acronym
- ELMOH
- Status last verified
- Jul 2024
- First submitted
- 6 May 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data will be put in Redcap. At inclusion, at inclusion +2h, at inclusion +24 and at inclusion +48h: a clotting panel and clinical observation about bleedina and clotting will be performed.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra Corporeal Life Support and Modification of Hemostasis
- ClinicalTrials.gov ID
- NCT04912336
- Acronym / sponsor ID
- ELMOH / BC-07099
- Conditions
- Bleeding Disorder, Extra Corporeal Life Support, Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 3 Jun 2021 (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.
To evaluate change in coagulation tests during a 48-h period after initiation VV-ECMO and VA-ECMO.
(ECMO= Extra Corporeal Membrane Oxygenator) Assessment of bleeding during Veno-Venous Extracoporeal Membrane Oxygenator (VV-ECMO) and Veno-Arterial Extracoporeal Membrane Oxygenator (VA-ECMO).
Detailed description
This is a multi-center, prospective, pilot cohort study, performed in the Intensive Care Units (ICUs) of the Ghent University Hospital, CHU Liège, University Hospital Brussels, and University Hospital Munster.
Each group will contain 20 subjects; in total there will be 40 subjects 2 groups of 20 patients GROUP 1: VV-ECMO n = 20 GROUP 2: VA-ECMO n = 20
- Demographics: age, sex, comorbidities, medication, reason for ECMO therapy
- Simplified Acute Physiology Score (SAPS) 3 at time of ICU admission.
- Components of the Sequential Organ Failure Assessment score daily (based on worst value of each component of the score)
- ECMO characteristics (place of cannulation, type of cannulas, oxygenator, bloodflow, gasflow and pressure registrations)
- Incidence and severity of bleeding, scored according to the GUSTO and BARC scores
- Coagulation profile: At inclusion (before heparine infusion is started), 2h after start of therapy, 24h, and 48h, and at specific moments of clinical suspicion of profound altered hemostasis. We defined a coagulation profile as a set of tests that includes
- prothrombin time (PT), international normalized ratio (INR)
- activated partial thromboplastin time (aPTT) and heparin ratio
- the fibrinogen level
- platelets
- ACT (iACT®, …)
- D-dimer
- ROTEM (extem, intem, heptem) or TEG (Utrecht)
- AT III
- anti Xa
- Temperature daily (H/L) (core)
- Patient characteristics that may influence coagulation or the results of coagulation tests: body weight, Body Mass Index, drugs, C-reactive protein (as a marker for inflammation), Hemoglobin level, LDH, unconjugated bilirubin, (or haptoglobine or plasma free haemoglobin, if tested)
- Heparin dose
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VV-ECMO | – | Diagnostic Test: Standard coagulation profile, Diagnostic Test: Specific coagulation tests, Other: Bleeding ScoresPatients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator. |
| VA-ECMO | – | Diagnostic Test: Standard coagulation profile, Diagnostic Test: Specific coagulation tests, Other: Bleeding ScoresPatients supported because of circulatory failure by Veno-Arterial Extra Corporeal Membrane Oxygenator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * GROUP 1: patients who will be initiated on VV-ECMO within a 12-h period * GROUP 2: patients who will be initiated on VA-ECMO within a 12-h period
Key inclusion criteria (4 listed)
- GROUP 1: patients who will be initiated on VV-ECMO within a 12-h period
- GROUP 2: patients who will be initiated on VA-ECMO within a 12-h period
- ≥ 18 years
- Signed Informed Consent, signed by subject or authorized representative
Key exclusion criteria (1 listed)
- Expected survival <48-h Known coagulopathy Pregnancy
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 |
|---|---|---|
| Standard coagulation profileprothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount | Diagnostic test | VA-ECMO, VV-ECMO |
| Specific coagulation testsAT III, anti Xa, ACT, ROTEM | Diagnostic test | VA-ECMO, VV-ECMO |
| Bleeding ScoresGlobal Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC) | Other | VA-ECMO, VV-ECMO |
Primary outcome
Thrombocytopenia
Time frame: 48 hours
Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients
5 secondary outcomes
Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria
Time frame: 48 hours
Clotting problems
Time frame: 48 hours
Need for transfusion
Time frame: 48 hours
Change in visco-elastic testing
Time frame: At 2 hours, 24 hours, 48 hours
Survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Undecided. All data will be put in Redcap. At inclusion, at inclusion +2h, at inclusion +24 and at inclusion +48h: a clotting panel and clinical observation about bleedina and clotting will be performed.
Related trials for Bleeding Disorder
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Harlinde Peperstraete, MD principal investigator
University Hospital, Ghent
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding Disorder and Extra Corporeal Life Support, run by University Hospital, Ghent at 6 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Thrombocytopenia (time frame: 48 hours). 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 30 Jul 2024.