Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03613584
Status:
UNKNOWN
Last Update Posted:
2020-03-12
First Post:
2018-03-22
Brief Title:
Von Willebrand Factor Concentrate During ECMO Support
Sponsor:
Tirol Kiniken GmbH
Organization:
Tirol Kiniken GmbH
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 andor 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None