跳至主要内容
临床试验/NCT04951999
NCT04951999已完成不适用

AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年12月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Von Willebrand factor high molecular weight multimers (HMWM) ratio

研究概览

简要总结

The primary objective of this study is to determine whether preserved pulsatility for patients supported by CF-LVAD (continuous flow Left Ventricular Assist Device) is associated with less acquired deficiency of the Von Willebrand factor, a blood glycoprotein involved in hemostasis.

详细描述

Implantation of LVADs (Left Ventricular Assist Device) is a medium to long-term therapeutic option for patients with end-stage heart failure and isolated left ventricular dysfunction. Nevertheless, LVADs use remain limited by the frequency of their adverse effects, most of which being unpredictable. In the literature, loss of pulsatility seems to be associated with CF-LVADs complications, including bleeding. Accordingly, the primary objective of this study is to determine whether patient's preserved pulsatility is associated with less acquired deficiency of the Von Willebrand factor (VWF), a blood glycoprotein involved in hemostasis. This deficiency, characterized by a decrease or absence of VWF High Molecular Weight Multimers (HMWMs), is present to varying degrees in almost all patients with LVADs and is a major risk factor for bleeding complications in these patients. Pulsatility is estimated by the patient's blood pressure differential, measured 1) at discharge from the operating room (=transfer to care), 2) at discharge from care (=transfer to his or her room), 3) at discharge from the hospital (=transfer to rehabilitation), and then at each follow-up visit up to 6 months post-implantation. The primary endpoint is to determine whether a preserved pulsatility is associated with less acquired deficiency of the Von Willebrand factor ratio of High Molecular Weight Multimers (HMWMs).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients over 18 years of age
  • •Patients for whom a decision to implant a left-sided monoventricular assist has been retained after discussion in the RCP of heart failure, transplantation and circulatory assistance (whatever the therapeutic strategy envisaged: waiting for transplantation, recovery or destination therapy).
  • •Patients affiliated to a social security system (beneficiaries or beneficiaries entitled to benefits, excluding AME)
  • •Signature of an informed consent by the patient or by the trusted person, or a close relative, if the patient is not able to do so

排除标准

  • •Heart transplant patients
  • •Patients who already had LVAD
  • •Chronic renal failure patients on dialysis
  • •Patients refusing to give informed consent
  • •Patients deprived of liberty or under legal protection (guardianship, curators)
  • •Pregnant or breastfeeding women
  • •Ongoing participation in another intervention research protocol except LEVOECMO project (NCT04728932) and ANCHOR project (NCT04184635)

研究组 & 干预措施

Blood sampling

Other

干预措施: Blood sampling (Other)

结局指标

主要结局

Von Willebrand factor high molecular weight multimers (HMWM) ratio

时间窗: 30 days after LVAD IMPLANTATION

Comparison of Von Willebrand factor high molecular weight multimers (HMWM) ratio at LVAD pre-implantation and at day 30. Measure of an correlation between preserved pulsatility and the HMWM ratio evolution during the first month after implantation.

次要结局

  • Aortic valve fusion(6 months)
  • Vascular endothelium dysfunction(6 months)
  • Prolonged systemic inflammatory reaction syndrome(6 months)
  • Aortic valve insufficiency(6 months)
  • Platelet dysfunction(6 months)
  • Severe postoperative gastrointestinal bleeding(6 months)
  • Post-operative right ventricular failure(6 months)
  • Post-operative transient or permanent ischemic attack(6 months)
  • Evolution of immune responses(6 months)
  • Evaluation of cardiac recovery(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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