Von Willebrand DiseasesWITECMO-HNCT03070912
Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients
An observational study of Von Willebrand Diseases, run by University Hospital, Lille at 7 sites in France.
Trial summary
ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are increasingly used. However bleeding complications occurring in up to 50% of patients are poorly understood and worsen the overall results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Von Willebrand Diseases
- How many people
- 257 participants
- Where
- 7 sitesFrance
- Study dates
- 19 Jan 2018to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients older than 18 years receiving either veno-arterial or even-venous ECMO and referred at Lille University Hospital
Who may be able to join
- informed consent of patient or person in charge
- patient supplied by an ECMO for cardiac or respiratory failure and referred to Lille University Hospital
- patient affiliated to "french social security"
Who cannot join
- pregnant woman
- no consent
- no affiliation to
- patient affiliated to '
- preexisting bleeding disorders
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CH ARRAS
Arras
CH Boulogne
Boulogne-sur-Mer
CH DOUAI
Douai
CH Dunkerque
Dunkirk, 59385
Hôpital Cardiologie, CHU
Lille
Ch Tourcoing
Tourcoing
Ch Valenciennes
Valenciennes
About this study
Official title: Study of the Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients of a Veino Arterial or Veinous ECMO
ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are increasingly used. However bleeding complications occurring in up to 50% of patients are poorly understood and worsen the overall results. The aim is to investigate the occurence of bleeding and its frequency according to the type of ECMO either veno-arterial or veno-venous. The investigators also want to assess the relation of bleeding with von Willebrand Factor defects.
- Conditions
- Von Willebrand Diseases
- Keywords
- mechanical circulatory support, bleeding, acquired von willebrand disease, acquired von willebrand disease
- Medical subject headings
- von Willebrand Diseases, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of major bleeding
Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO
Measured: During ECMO support, up to 3 weeks after implantation
Secondary outcomes (8)
Number of Participants With Abnormal VWF functional activities and multimeric profile according to the type of ECMO support (VA- or VV-ECMO)
Willebrand Factor abnormalities according to the type of ECMO support (VA- or VV-ECMO)
Measured: 1 hour, 24 hours and day seven after implantation
Number of Participants With Abnormal VWF functional activities and multimeric profile before and after the first reduction in VA-ECMO flow rate
Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO
Measured: During ECMO support, up to 3 weeks after implantation
Number of Participants With Abnormal VWF functional activities and multimeric profile in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure
Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO
Measured: During ECMO support, up to 3 weeks after implantation
Number of Participants With major bleeding events (BARC classification) before and after the first reduction in VA-ECMO flow rate
Willebrand Factor abnormalities according major bleeding events under VA-ECMO
Measured: During ECMO support, up to 3 weeks after implantation
Number of Participants With major bleeding events (BARC classification) in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure
Willebrand Factor abnormalities according major bleeding events under VA-ECMO
Measured: During ECMO support, up to 3 weeks after implantation
Frequency of major bleeding events according to diabetes status
Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO in patients with and without diabetes
Measured: During ECMO support, up to 3 weeks after implantation
Frequency of major thrombotic events according to diabetes status
Number of major thrombotic events (stroke, transient ischemic attack, acute limb ischemia, ECMO thrombosis) occurring within the time course of support by ECMO in patients with and without diabetes
Measured: During ECMO support, up to 3 weeks after implantation
Frequency of pro-thrombotic biological abnormalities
Measurement of plasma free hemoglobin, leuco-platelet aggregates and neutrophil extracellular traps levels
Measured: During ECMO support, up to 3 weeks after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start19 Jan 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Von Willebrand DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine RAUCH, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070912
- Sponsor's protocol ID
- 2015_83
- Other IDs
- 2017-A00256-47
- Acronym
- WITECMO-H
- Status last verified
- Nov 2025
- First submitted
- 13 Feb 2017
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moussa MD, Abou-Arab O, Staessens S, Jungling M, Labreuche J, Lamer A, Beyls C, Rousse N, Rauch A, Loobuyck V, Beaudeux C, Pierache A, Deblauwe D, Corseaux D, Dubernet M, Guilbart M, Thellier L, Mahjoub Y, Juthier F, Dupont H, De Meyer SF, Vincentelli A, Susen S, Robin E. Comparison of the effects of phosphorylcholin versus heparin-based surface coating on clinical and histologic outcomes during veno-arterial extracorporeal membrane oxygenation support: a propensity score weighted analysis. J Thromb Haemost. 2025 Jun;23(6):1879-1892. doi: 10.1016/j.jtha.2025.02.020. Epub 2025 Feb 26.
PubMed 40020783Rauch A, Dupont A, Rosa M, Desvages M, Le Tanno C, Abdoul J, Didelot M, Ung A, Ruez R, Jeanpierre E, Daniel M, Corseaux D, Spillemaeker H, Labreuche J, Pradines B, Rousse N, Lenting PJ, Moussa MD, Vincentelli A, Bordet JC, Staels B, Vincent F, Denis CV, Van Belle E, Casari C, Susen S. Shear Forces Induced Platelet Clearance Is a New Mechanism of Thrombocytopenia. Circ Res. 2023 Oct 27;133(10):826-841. doi: 10.1161/CIRCRESAHA.123.322752. Epub 2023 Oct 26.
PubMed 37883587
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients of a Veino Arterial or Veinous ECMO
- ClinicalTrials.gov ID
- NCT03070912
- Acronym / sponsor ID
- WITECMO-H / 2015_83
- Conditions
- Von Willebrand Diseases
- Keywords
- mechanical circulatory support, bleeding, acquired von willebrand disease, acquired von willebrand disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Mar 2017 (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.
ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are increasingly used. However bleeding complications occurring in up to 50% of patients are poorly understood and worsen the overall results. The aim is to investigate the occurence of bleeding and its frequency according to the type of ECMO either veno-arterial or veno-venous. The investigators also want to assess the relation of bleeding with von Willebrand Factor defects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients older than 18 years receiving either veno-arterial or even-venous ECMO and referred at Lille University Hospital
Key inclusion criteria (3 listed)
- informed consent of patient or person in charge
- patient supplied by an ECMO for cardiac or respiratory failure and referred to Lille University Hospital
- patient affiliated to "french social security"
Key exclusion criteria (5 listed)
- pregnant woman
- no consent
- no affiliation to
- patient affiliated to '
- preexisting bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of major bleeding
Time frame: During ECMO support, up to 3 weeks after implantation
Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO
8 secondary outcomes
Number of Participants With Abnormal VWF functional activities and multimeric profile according to the type of ECMO support (VA- or VV-ECMO)
Time frame: 1 hour, 24 hours and day seven after implantation
Number of Participants With Abnormal VWF functional activities and multimeric profile before and after the first reduction in VA-ECMO flow rate
Time frame: During ECMO support, up to 3 weeks after implantation
Number of Participants With Abnormal VWF functional activities and multimeric profile in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure
Time frame: During ECMO support, up to 3 weeks after implantation
Number of Participants With major bleeding events (BARC classification) before and after the first reduction in VA-ECMO flow rate
Time frame: During ECMO support, up to 3 weeks after implantation
Number of Participants With major bleeding events (BARC classification) in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure
Time frame: During ECMO support, up to 3 weeks after implantation
Frequency of major bleeding events according to diabetes status
Time frame: During ECMO support, up to 3 weeks after implantation
Frequency of major thrombotic events according to diabetes status
Time frame: During ECMO support, up to 3 weeks after implantation
Frequency of pro-thrombotic biological abnormalities
Time frame: During ECMO support, up to 3 weeks after implantation
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 28 Nov 2025.
- Background: PubMed 40020783Moussa MD, Abou-Arab O, Staessens S, Jungling M, Labreuche J, Lamer A, Beyls C, Rousse N, Rauch A, Loobuyck V, Beaudeux C, Pierache A, Deblauwe D, Corseaux D, Dubernet M, Guilbart M, Thellier L, Mahjoub Y, Juthier F, Dupont H, De Meyer SF, Vincentelli A, Susen S, Robin E. Comparison of the effects of phosphorylcholin versus heparin-based surface coating on clinical and histologic outcomes during veno-arterial extracorporeal membrane oxygenation support: a propensity score weighted analysis. J Thromb Haemost. 2025 Jun;23(6):1879-1892. doi: 10.1016/j.jtha.2025.02.020. Epub 2025 Feb 26.
- Results publication: PubMed 37883587Rauch A, Dupont A, Rosa M, Desvages M, Le Tanno C, Abdoul J, Didelot M, Ung A, Ruez R, Jeanpierre E, Daniel M, Corseaux D, Spillemaeker H, Labreuche J, Pradines B, Rousse N, Lenting PJ, Moussa MD, Vincentelli A, Bordet JC, Staels B, Vincent F, Denis CV, Van Belle E, Casari C, Susen S. Shear Forces Induced Platelet Clearance Is a New Mechanism of Thrombocytopenia. Circ Res. 2023 Oct 27;133(10):826-841. doi: 10.1161/CIRCRESAHA.123.322752. Epub 2023 Oct 26.
- Individual participant dataSharing planned: No
Related trials for Von Willebrand Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
RecruitingPhase 3
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD
Von Willebrand Diseases
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease
Von Willebrand Disease, Type 3
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.
Antoine RAUCH, MD,PhD principal investigator
University Hospital, Lille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Willebrand Diseases, run by University Hospital, Lille at 7 sites in France.
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 5 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Frequency of major bleeding (time frame: During ECMO support, up to 3 weeks after implantation). 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 NCT03070912, which also lists 2 linked publications.
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 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.