End-stage Heart FailureHemostVADNCT03966313
Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
An observational study of End-stage Heart Failure, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Heart Failure
- What is being tested?
- ventricular assist device implantation
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2019to 13 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: Patient with end-stage heart failure (acute or chronic) under surgery for implantation of a ventricular assist device.
Who may be able to join
- Age over 18 years old
- Who gave his consent to the study
- With an end-stage heart-failure
- Under surgery for a ventricular assist device implantation
- Scheduled or in emergency
Who cannot join
- Preoperative anemia less than 7 g/dL
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.
The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.
- Conditions
- End-stage Heart Failure
- Being tested
- ventricular assist device implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventricular assist device implantationDevice
Blood sampling in patients under surgery for ventricular assist device implantation at five time points:
- After anesthetic induction
- Before starting the device
- 2h, 6h and 48h after starting the device
What is being measured
The primary outcome is the main question the study is designed to answer.
Von Willebrand Factor activity
Change of Von Willebrand Factor from Baseline to 48 hours
Measured: From Baseline to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start21 Jun 2019
- Primary completion13 Apr 2024
- Study completion13 Apr 2024
Why it stopped: Due to inclusion difficulties following the evolution of surgical indications, which were clearly restricted, making patient inclusion too complex.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966313
- Sponsor's protocol ID
- 7287
- Acronym
- HemostVAD
- Status last verified
- Mar 2025
- First submitted
- 17 May 2019
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT03966313
- Acronym / sponsor ID
- HemostVAD / 7287
- Conditions
- End-stage Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to inclusion difficulties following the evolution of surgical indications, which were clearly restricted, making patient inclusion too complex.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 13 Apr 2024 (actual)
- Study completion
- 13 Apr 2024 (actual)
- First posted
- 29 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.
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.
The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.
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
- Patient with end-stage heart failure (acute or chronic) under surgery for implantation of a ventricular assist device.
Key inclusion criteria (5 listed)
- Age over 18 years old
- Who gave his consent to the study
- With an end-stage heart-failure
- Under surgery for a ventricular assist device implantation
- Scheduled or in emergency
Key exclusion criteria (5 listed)
- Preoperative anemia less than 7 g/dL
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Pregnancy
- Breastfeeding
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 |
|---|---|---|
| ventricular assist device implantationBlood sampling in patients under surgery for ventricular assist device implantation at five time points: * After anesthetic induction * Before starting the device * 2h, 6h and 48h after starting the device | Device | – |
Primary outcome
Von Willebrand Factor activity
Time frame: From Baseline to 48 hours
Change of Von Willebrand Factor from Baseline to 48 hours
Results and safety
The study was stopped early (reason given: Due to inclusion difficulties following the evolution of surgical indications, which were clearly restricted, making patient inclusion too complex.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Heart Failure, run by University Hospital, Strasbourg, France 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 5 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: stopped early, as of the sponsor's last update on 25 Mar 2025. 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.
Are results available for this study?
The study was stopped early (reason given: Due to inclusion difficulties following the evolution of surgical indications, which were clearly restricted, making patient inclusion too complex.). 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?
Von Willebrand Factor activity (time frame: From Baseline to 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 25 Mar 2025.