免费获得国外相关药品，最快 1 个工作日回馈药物信息
Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation (HemostVAD)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| End-stage Heart Failure | Device: ventricular assist device implantation |
| Study Type : | Observational |
| Estimated Enrollment : | 45 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation |
| Actual Study Start Date : | June 21, 2019 |
| Estimated Primary Completion Date : | June 21, 2022 |
| Estimated Study Completion Date : | June 21, 2022 |
- Von Willebrand Factor activity [ Time Frame: From Baseline to 48 hours ]Change of Von Willebrand Factor from Baseline to 48 hours
Biospecimen Retention: Samples Without DNA
- Whole blood
- Plasma
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 17, 2019 | ||||
| First Posted Date | May 29, 2019 | ||||
| Last Update Posted Date | April 22, 2020 | ||||
| Actual Study Start Date | June 21, 2019 | ||||
| Estimated Primary Completion Date | June 21, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Von Willebrand Factor activity [ Time Frame: From Baseline to 48 hours ] Change of Von Willebrand Factor from Baseline to 48 hours
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation | ||||
| Official Title | Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation | ||||
| Brief 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. 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description:
|
||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patient with end-stage heart failure (acute or chronic) under surgery for implantation of a ventricular assist device. | ||||
| Condition | End-stage Heart Failure | ||||
| Intervention | Device: ventricular assist device implantation
Blood sampling in patients under surgery for ventricular assist device implantation at five time points:
|
||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
45 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 21, 2022 | ||||
| Estimated Primary Completion Date | June 21, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
|
||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03966313 | ||||
| Other Study ID Numbers | 7287 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | University Hospital, Strasbourg, France | ||||
| Study Sponsor | University Hospital, Strasbourg, France | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University Hospital, Strasbourg, France | ||||
| Verification Date | April 2020 | ||||
