Heart FailurePhase 3PHAMNCT02488525
Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support
A Phase 3 study testing Prophylactic treatment with Wilfactin in people with Heart Failure, run by University Hospital, Lille at 1 site in France.
Trial summary
Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Prophylactic treatment with Wilfactin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2016to 5 Sep 2018
- Phase
- Phase 3
- 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
- Adult patients > 18 years who need a CF-LVAD due to advanced heart failure.
- Functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >180 sec and or VWF:Act/VWF:Ag≤ 0.7)
- Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)
Who cannot join
- Treatment with Wilfactin® within the last seven days
- Previous adverse reaction to Wilfactin®
- Absence of functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >250 sec and or VWF:Act/VWF:Ag<0.7)
- Patient with a known thrombophilia
- Patient with a known severe bleeding disorder
- Patient refusal or environment
- Minor patients
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. Adult patients with functional defects of VWF measured after implantation of continuous LVAD are randomly assigned to prophylactic treatment.
Read the detailed description
This time point was chosen because the bleeding events are maximal within the first 3 months after implantation.
- Adult patients > 18 years who need a CF-LVAD due to advanced heart failure.
- Functional To determine the potential indication of Wilfactin® in the field of CF-LVAD and avoid widespread use and to establish evidence-based recommendation To improve the knowledge of the role of VWF concentrate in bleeding and angiogenesis after CF-LVAD implantation and to provide some results about mechanism involved angiogenesis or hemostasis.
- Conditions
- Heart Failure
- Being tested
- Prophylactic treatment with Wilfactin
- Keywords
- Acquired Von Willebrand, Gastro-intestinal bleeding, LVAD
- Medical subject headings
- Heart Failure, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic treatment with WilfactinDrug
Also called Prophylactic treatment with VWF factor concentrate
Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.
| Study group | Role | What they receive |
|---|---|---|
| Wilfactin | Experimental | Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care. Receives: Drug: Prophylactic treatment with Wilfactin |
| Control | No intervention | The control group will receive all treatments according to standard of care which does not include prophylactic administration of Wilfactin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinically significant bleeding within 3 months after implantation
A clinically significant bleeding event is defined as internal or external bleeding leading to death or prolonged hospitalization or requiring re-hospitalization, surgery or transfusion of at least 3 units of packed red blood cells or hemoglobin drop> 3g/dL and/or refractory to conventional approach
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start20 Jan 2016
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Why it stopped: deficient inclusion
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 Heart FailureStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Susen Sophie, MD, PhD, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488525
- Sponsor's protocol ID
- 2015_06
- Other IDs
- 2015-001231-20, PHRC-14-0469, 2015
- Acronym
- PHAM
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2015
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vincentelli A, Susen S, Le Tourneau T, Six I, Fabre O, Juthier F, Bauters A, Decoene C, Goudemand J, Prat A, Jude B. Acquired von Willebrand syndrome in aortic stenosis. N Engl J Med. 2003 Jul 24;349(4):343-9. doi: 10.1056/NEJMoa022831.
PubMed 12878741Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, Hurt C, Banfi C, Rousse N, Godier A, Caron C, Elkalioubie A, Corseaux D, Dupont A, Zawadzki C, Delhaye C, Mouquet F, Schurtz G, Deplanque D, Chinetti G, Staels B, Goudemand J, Jude B, Lenting PJ, Susen S. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 Mar 27;116(7):1193-201. doi: 10.1161/CIRCRESAHA.116.305046. Epub 2015 Feb 10.
PubMed 25670067
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support
- ClinicalTrials.gov ID
- NCT02488525
- Acronym / sponsor ID
- PHAM / 2015_06
- Conditions
- Heart Failure
- Keywords
- Acquired Von Willebrand, Gastro-intestinal bleeding, LVAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: deficient inclusion
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies, Ministry of Health, France
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 2 Jul 2015 (estimated)
- 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.
Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. Adult patients with functional defects of VWF measured after implantation of continuous LVAD are randomly assigned to prophylactic treatment.
Detailed description
This time point was chosen because the bleeding events are maximal within the first 3 months after implantation.
- Adult patients > 18 years who need a CF-LVAD due to advanced heart failure.
- Functional To determine the potential indication of Wilfactin® in the field of CF-LVAD and avoid widespread use and to establish evidence-based recommendation To improve the knowledge of the role of VWF concentrate in bleeding and angiogenesis after CF-LVAD implantation and to provide some results about mechanism involved angiogenesis or hemostasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wilfactin | Experimental | Drug: Prophylactic treatment with WilfactinProphylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care. |
| Control | No intervention | –The control group will receive all treatments according to standard of care which does not include prophylactic administration of Wilfactin® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients > 18 years who need a CF-LVAD due to advanced heart failure.
- Functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >180 sec and or VWF:Act/VWF:Ag≤ 0.7)
- Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)
Key exclusion criteria (8 listed)
- Treatment with Wilfactin® within the last seven days
- Previous adverse reaction to Wilfactin®
- Absence of functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >250 sec and or VWF:Act/VWF:Ag<0.7)
- Patient with a known thrombophilia
- Patient with a known severe bleeding disorder
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 |
|---|---|---|
| Prophylactic treatment with WilfactinAlso: Prophylactic treatment with VWF factor concentrateProphylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care. | Drug | Wilfactin |
Primary outcome
Percentage of patients with clinically significant bleeding within 3 months after implantation
Time frame: 3 months
A clinically significant bleeding event is defined as internal or external bleeding leading to death or prolonged hospitalization or requiring re-hospitalization, surgery or transfusion of at least 3 units of packed red blood cells or hemoglobin drop> 3g/dL and/or refractory to conventional approach
Results and safety
The study was stopped early (reason given: deficient inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Background: PubMed 12878741Vincentelli A, Susen S, Le Tourneau T, Six I, Fabre O, Juthier F, Bauters A, Decoene C, Goudemand J, Prat A, Jude B. Acquired von Willebrand syndrome in aortic stenosis. N Engl J Med. 2003 Jul 24;349(4):343-9. doi: 10.1056/NEJMoa022831.
- Background: PubMed 25670067Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, Hurt C, Banfi C, Rousse N, Godier A, Caron C, Elkalioubie A, Corseaux D, Dupont A, Zawadzki C, Delhaye C, Mouquet F, Schurtz G, Deplanque D, Chinetti G, Staels B, Goudemand J, Jude B, Lenting PJ, Susen S. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 Mar 27;116(7):1193-201. doi: 10.1161/CIRCRESAHA.116.305046. Epub 2015 Feb 10.
- 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.
Susen Sophie, MD, PhD study chair
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prophylactic treatment with Wilfactin in people with Heart Failure, run by University Hospital, Lille at 1 site 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 8 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: stopped early, as of the sponsor's last update on 11 Jul 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: deficient inclusion). Results are not available in the source record.
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 patients with clinically significant bleeding within 3 months after implantation (time frame: 3 months). 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 NCT02488525, 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 11 Jul 2019.