Acquired Von Willebrand DiseasePhase 2NCT03613584
Von Willebrand Factor Concentrate During ECMO Support
A Phase 2 study testing Von Willebrand Factor and Saline Solution in people with Acquired Von Willebrand Disease, run by Tirol Kiniken GmbH at 2 sites in Austria.
Trial summary
During treatments with extracorporeal circuits such as extracorporeal membrane oxygenation (ECMO) degradation of high molecular weight (HMW) of von Willebrand factor (vWF) multimers occur leading to an acquired von Willebrand disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Von Willebrand Disease
- What is being tested?
- Von Willebrand Factor and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesAustria
- Study dates
- 16 Apr 2018to 10 Mar 2021
- Phase
- Phase 2
- 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
- Patients with the need of veno-arterial or veno-venous ECMO for a minimum of 48 hours
- Age ≥ 18 years
Who cannot join
- Patient with known thromboembolic event in the last 30 days
- Inevitable lethal course
- Severe Liver failure: Quick < 30 %
- Pregnancy
- Patient with known refusal of a participation in this clinical trial
- Active participation in another clinical trial
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study or confound the ability to interpret data from the study
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University Innsbruck / Department for Anesthesia and Intensive Care Medicine
Innsbruck, 6020
Medical University Innsbruck / Department for General and Surgical Critical Care Medicine
Innsbruck, 6020
About this study
Official title: A Double-blind, Placebo-controlled Pilot Trial to Investigate the Administration of Von Willebrand Factor Concentrate (Willfact®, LFB France) in Adult Patients During Extracorporeal Membrane Oxygenation
During treatments with extracorporeal circuits such as extracorporeal membrane oxygenation (ECMO) degradation of high molecular weight (HMW) of von Willebrand factor (vWF) multimers occur leading to an acquired von Willebrand disease. This disease is associated with increased bleeding and requirement for the transfusion with allogenic blood products especially packed red blood cells (PRBCs). A continuous treatment with von Willebrand factor concentrate (vWFC) may restore the multimers and bleeding can be avoided. Therefore a randomized, double-blind, prospective, controlled, two-arm clinical trial was designed, comparing patients receiving vWFC versus placebo.
Read the detailed description
Increased shear stress during mechanical circulatory support (MCS) by extracorporeal membrane oxygenation (ECMO) and ventricular assist devices (VAD) can provoke premature degradation of high molecular weight (HMW) of von Willebrand factor (vWF) multimers. In patients with intractable cardiac and/or respiratory failure requiring emergency ECMO support, the investigators recently demonstrated an essential decrease in high molecular weight (HMW) vWF multimer bands 24 and 48 hours after initiation of ECMO compared to baseline. Blood loss and transfusion requirement during and shortly after ECMO support may be strengthened by loss of HMW vWF multimers.
Administration of vWF concentrates may support restoration of primary hemostasis in patients during ECMO support. Consequently the need for packed red blood cells (PRBCs) during ECMO support may be reduced thus positively influencing morbidity and mortality of ECMO patients. The investigators hypothesize, that treatment with vWF concentrate reduces the need for PRBCs during ECMO support. Therefore the primary aim of this clinical trial is to find out if the need of PRBCs differs in the group receiving a von Willebrand factor concentrate (vWFC), or the placebo group (saline).
This clinical trial is planned as a randomized, double-blind, prospective, controlled, two-arm, two-center study. Patients with intractable cardiac and/or respiratory failure requiring emergency ECMO support undergoing surgery (Department of Anaesthesiology and Intensive Care Medicine) or treated at the General and Surgical Intensive Care Unit (ACI), Traumatologic Intensive Care Unit (TICU), Cardiologic Intensive Care Unit (CCU) or the ICU of the Department of Visceral, Transplant and Thoracic Surgery at the Hospital Innsbruck (Tirol Kliniken GmbH), Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study, the patient will be randomized either to the group receiving vWFC or placebo S. Before the implementation of the ECMO the Baseline investigations need to be conducted. As soon as they are completed the ECMO cannula can be inserted.
The administration of the Investigational Medicinal Product (IMP) will be start within 24h after ECMO installation. Directly before IMP-start blood samples (Visit 2) will be drawn. After 24h (Visit 3), 60h (Visit 4) and on day 5 (Visit 5) of the start of the study medication visits will be conducted, whereas on day 5 (Visit 5) no special laboratory (measurement of HMW vWF) will be analyzed. If ECMO can be terminated, a visit (Visit 6) directly before the stop of the ECMO will be conducted. 36 h after the termination of the ECMO Visit 7 (termination) will be performed. If the ECMO is needed longer than 7 days, the administration of the IMP will be stopped on day 7 and a visit after 36 hours of IMP-stop will be done for safety reasons but without special laboratory. After 30 days an interview will be performed with the treating physician.
- Conditions
- Acquired Von Willebrand Disease
- Being tested
- Von Willebrand Factor, Saline Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Von Willebrand FactorDrug
Bolus and continuous infusion of the Investigational Medicinal Product (IMP) during extracorporeal membrane oxygenation (ECMO)
Saline SolutionDrug
Bolus and continuous infusion of the Investigational Medicinal Product (IMP) during extracorporeal membrane oxygenation (ECMO)
| Study group | Role | What they receive |
|---|---|---|
| Group W (von Willebrand factor concentrate) | Active comparator | The patient receives von Willebrand factor concentrate (vWFC) as a bolus of 25 IU/kg followed by a continuous infusion of 50 IU/kg/24h until the weaning from ECMO is completed or if ECMO is needed longer than 7 days, the administration of the Investigational Medicinal Product (IMP) will be stopped on the 7th day. Receives: Drug: Von Willebrand Factor |
| Group S (standard therapy with saline solution) | Placebo comparator | The patient receives the standard therapy plus an additional volume of saline solution equivalent to the amount of von Willebrand factor concentrate (vWFC) the patient would receive in Group W to keep the blind. The volume is given according to the VWFC-solution (0.25 ml/kg BW) what would be resulting from the patient's weight followed by a continuous saline infusion (0.50 ml/kg BW) until the weaning from ECMO is completed or if ECMO is needed longer than 7 days, the Investigational Medicinal Product (IMP) administration is stopped on the 7th day. Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion requirement of PRBC
Difference in the number of red blood cells concentrates between the treatment arms per day
Measured: Between start of IMP (Visit 2) until 24 hours after IMP-start (Visit 3)
Secondary outcomes (13)
Transfusion requirements of other allogenic blood products
Difference in the number of other high risk allogenic transfusion products (fresh frozen plasma and platelet concentrate) between the treatment arms per day
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Requirements of coagulation factor concentrates
Amount of coagulation factor concentrates given during ECMO support between the treatment arms per day
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Number of vWF-HMW multimer bands
Number of vWF multimer bands measured via SDS-agarose gel electrophoresis between the treatment arms
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Assessment of thromboelastometry
Difference in thromboelastometry between the treatment arms
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Changes in thrombocytes
Difference in platelet number
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Renal function
Difference in the daily urine output
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Number of participants with bleeding events
Number of patients with bleeding events assessed by a bleeding score based on Mazzeffi et al 2013
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Assessment vWF-HMW function
vWF function (vWF:Ag, vWF:RCo, and F:VIII) via photooptical measurement between the treatment arms
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Assessment of activated partial thromboplastin time (aPTT) assay
aPTT assay [seconds] between the treatment arms
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Changes in red blood cell number
Differences in red blood cell number and hemoglobin between the treatment arms
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Number of participants with thromboembolic events
Number of participants with thromboembolic events as assessed via duplex ultrasonic investigation of the cervical vessels (Carotis und Vertebralis) and major leg veins
Measured: 36 hours after IMP-Stop
Assessment of Prothrombin time (PT) assay
PT assay [%] between the treatment arms
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Assessment of activated clotting time (ACT)
ACT assay [seconds] between the treatment arms
Measured: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start16 Apr 2018
- Primary completion10 Mar 2021 (estimated)
- Study completion10 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acquired Von Willebrand DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tirol Kiniken GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- LFB BIOMEDICAMENTS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613584
- Sponsor's protocol ID
- ECMO-vWFC
- Status last verified
- Mar 2020
- First submitted
- 22 Mar 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tauber H, Streif W, Fritz J, Ott H, Weigel G, Loacker L, Heinz A, Velik-Salchner C. Predicting Transfusion Requirements During Extracorporeal Membrane Oxygenation. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):692-701. doi: 10.1053/j.jvca.2016.01.009. Epub 2016 Jan 11.
PubMed 27321792Tauber H, Ott H, Streif W, Weigel G, Loacker L, Fritz J, Heinz A, Velik-Salchner C. Extracorporeal membrane oxygenation induces short-term loss of high-molecular-weight von Willebrand factor multimers. Anesth Analg. 2015 Apr;120(4):730-6. doi: 10.1213/ANE.0000000000000554.
PubMed 25565317Velik-Salchner C, Eschertzhuber S, Streif W, Hangler H, Budde U, Fries D. Acquired von Willebrand syndrome in cardiac patients. J Cardiothorac Vasc Anesth. 2008 Oct;22(5):719-24. doi: 10.1053/j.jvca.2007.05.013. Epub 2007 Aug 3. No abstract available.
PubMed 18922429
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Pilot Trial to Investigate the Administration of Von Willebrand Factor Concentrate (Willfact®, LFB France) in Adult Patients During Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT03613584
- Acronym / sponsor ID
- ECMO-vWFC
- Conditions
- Acquired Von Willebrand Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Tirol Kiniken GmbHUniversity, hospital or other
- Collaborators
- LFB BIOMEDICAMENTS
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 10 Mar 2021 (estimated)
- First posted
- 3 Aug 2018 (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.
During treatments with extracorporeal circuits such as extracorporeal membrane oxygenation (ECMO) degradation of high molecular weight (HMW) of von Willebrand factor (vWF) multimers occur leading to an acquired von Willebrand disease. This disease is associated with increased bleeding and requirement for the transfusion with allogenic blood products especially packed red blood cells (PRBCs). A continuous treatment with von Willebrand factor concentrate (vWFC) may restore the multimers and bleeding can be avoided. Therefore a randomized, double-blind, prospective, controlled, two-arm clinical trial was designed, comparing patients receiving vWFC versus placebo.
Detailed description
Increased shear stress during mechanical circulatory support (MCS) by extracorporeal membrane oxygenation (ECMO) and ventricular assist devices (VAD) can provoke premature degradation of high molecular weight (HMW) of von Willebrand factor (vWF) multimers. In patients with intractable cardiac and/or respiratory failure requiring emergency ECMO support, the investigators recently demonstrated an essential decrease in high molecular weight (HMW) vWF multimer bands 24 and 48 hours after initiation of ECMO compared to baseline. Blood loss and transfusion requirement during and shortly after ECMO support may be strengthened by loss of HMW vWF multimers.
Administration of vWF concentrates may support restoration of primary hemostasis in patients during ECMO support. Consequently the need for packed red blood cells (PRBCs) during ECMO support may be reduced thus positively influencing morbidity and mortality of ECMO patients. The investigators hypothesize, that treatment with vWF concentrate reduces the need for PRBCs during ECMO support. Therefore the primary aim of this clinical trial is to find out if the need of PRBCs differs in the group receiving a von Willebrand factor concentrate (vWFC), or the placebo group (saline).
This clinical trial is planned as a randomized, double-blind, prospective, controlled, two-arm, two-center study. Patients with intractable cardiac and/or respiratory failure requiring emergency ECMO support undergoing surgery (Department of Anaesthesiology and Intensive Care Medicine) or treated at the General and Surgical Intensive Care Unit (ACI), Traumatologic Intensive Care Unit (TICU), Cardiologic Intensive Care Unit (CCU) or the ICU of the Department of Visceral, Transplant and Thoracic Surgery at the Hospital Innsbruck (Tirol Kliniken GmbH), Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study, the patient will be randomized either to the group receiving vWFC or placebo S. Before the implementation of the ECMO the Baseline investigations need to be conducted. As soon as they are completed the ECMO cannula can be inserted.
The administration of the Investigational Medicinal Product (IMP) will be start within 24h after ECMO installation. Directly before IMP-start blood samples (Visit 2) will be drawn. After 24h (Visit 3), 60h (Visit 4) and on day 5 (Visit 5) of the start of the study medication visits will be conducted, whereas on day 5 (Visit 5) no special laboratory (measurement of HMW vWF) will be analyzed. If ECMO can be terminated, a visit (Visit 6) directly before the stop of the ECMO will be conducted. 36 h after the termination of the ECMO Visit 7 (termination) will be performed. If the ECMO is needed longer than 7 days, the administration of the IMP will be stopped on day 7 and a visit after 36 hours of IMP-stop will be done for safety reasons but without special laboratory. After 30 days an interview will be performed with the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group W (von Willebrand factor concentrate) | Active comparator | Drug: Von Willebrand FactorThe patient receives von Willebrand factor concentrate (vWFC) as a bolus of 25 IU/kg followed by a continuous infusion of 50 IU/kg/24h until the weaning from ECMO is completed or if ECMO is needed longer than 7 days, the administration of the Investigational Medicinal Product (IMP) will be stopped on the 7th day. |
| Group S (standard therapy with saline solution) | Placebo comparator | Drug: Saline SolutionThe patient receives the standard therapy plus an additional volume of saline solution equivalent to the amount of von Willebrand factor concentrate (vWFC) the patient would receive in Group W to keep the blind. The volume is given according to the VWFC-solution (0.25 ml/kg BW) what would be resulting from the patient's weight followed by a continuous saline infusion (0.50 ml/kg BW) until the weaning from ECMO is completed or if ECMO is needed longer than 7 days, the Investigational Medicinal Product (IMP) administration is stopped on the 7th day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with the need of veno-arterial or veno-venous ECMO for a minimum of 48 hours
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- Patient with known thromboembolic event in the last 30 days
- Inevitable lethal course
- Severe Liver failure: Quick < 30 %
- Pregnancy
- Patient with known refusal of a participation in this clinical trial
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 |
|---|---|---|
| Von Willebrand FactorBolus and continuous infusion of the Investigational Medicinal Product (IMP) during extracorporeal membrane oxygenation (ECMO) | Drug | Group W (von Willebrand factor concentrate) |
| Saline SolutionBolus and continuous infusion of the Investigational Medicinal Product (IMP) during extracorporeal membrane oxygenation (ECMO) | Drug | Group S (standard therapy with saline solution) |
Primary outcome
Transfusion requirement of PRBC
Time frame: Between start of IMP (Visit 2) until 24 hours after IMP-start (Visit 3)
Difference in the number of red blood cells concentrates between the treatment arms per day
13 secondary outcomes
Transfusion requirements of other allogenic blood products
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Requirements of coagulation factor concentrates
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Number of vWF-HMW multimer bands
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Assessment of thromboelastometry
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Changes in thrombocytes
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Renal function
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Number of participants with bleeding events
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Assessment vWF-HMW function
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Assessment of activated partial thromboplastin time (aPTT) assay
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Changes in red blood cell number
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Number of participants with thromboembolic events
Time frame: 36 hours after IMP-Stop
Assessment of Prothrombin time (PT) assay
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Assessment of activated clotting time (ACT)
Time frame: Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Background: PubMed 27321792Tauber H, Streif W, Fritz J, Ott H, Weigel G, Loacker L, Heinz A, Velik-Salchner C. Predicting Transfusion Requirements During Extracorporeal Membrane Oxygenation. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):692-701. doi: 10.1053/j.jvca.2016.01.009. Epub 2016 Jan 11.
- Background: PubMed 25565317Tauber H, Ott H, Streif W, Weigel G, Loacker L, Fritz J, Heinz A, Velik-Salchner C. Extracorporeal membrane oxygenation induces short-term loss of high-molecular-weight von Willebrand factor multimers. Anesth Analg. 2015 Apr;120(4):730-6. doi: 10.1213/ANE.0000000000000554.
- Background: PubMed 18922429Velik-Salchner C, Eschertzhuber S, Streif W, Hangler H, Budde U, Fries D. Acquired von Willebrand syndrome in cardiac patients. J Cardiothorac Vasc Anesth. 2008 Oct;22(5):719-24. doi: 10.1053/j.jvca.2007.05.013. Epub 2007 Aug 3. No abstract available.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Von Willebrand Factor and Saline Solution in people with Acquired Von Willebrand Disease, run by Tirol Kiniken GmbH at 2 sites in Austria.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Transfusion requirement of PRBC (time frame: Between start of IMP (Visit 2) until 24 hours after IMP-start (Visit 3)). 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 NCT03613584, which also lists 3 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 12 Mar 2020.