Phase 4 Study Determining the Safety of Enoxaparin Prophylaxis in Critically Ill Adults With Severe Renal Insufficiency
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine the rate of patient enrollment into this study within the 24 month allotted time frame of recruitment
研究概览
简要总结
The investigators study is the first step (a pilot study) in determining whether the manufacturer's recommended dose of a blood thinner called enoxaparin, in adults who are patients in an intensive care unit and have severely reduced kidney function (less than or equal to approximately 30% of their normal function) is safe with respect to the adverse effect of bleeding.
The investigators hypothesis is that studying these patients, going forward in time, without interfering with their care, to eventually determine if this blood thinner is safe at reduced doses, is feasible.
详细描述
Objectives:
To determine the feasibility of conducting a single centre, open-label, prospective study to inform preparation for a prospective phase III study evaluating the efficacy & safety of enoxaparin prophylaxis in critically ill adults with creatinine clearance < 30 mL/min.
Study Design:
A pilot open-label, single-arm, prospective study.
Patients:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •body weight ≥ 45 kg
- •expected ICU length of stay ≥ 72 hours
- •severe renal insufficiency, defined by calculated creatinine clearance (CrCl) < 30 mL/min using the Cockcroft-Gault formula
- •All patients with severe renal insufficiency at ICU admission will be included, regardless of chronicity of renal disease. This includes patients with pre-existing dialysis dependence via intermittent hemodialysis and peritoneal dialysis; patients with acute kidney injury requiring SLED (sustained low-efficiency dialysis) will also be included.
排除标准
- •neurological surgery in last 3 months
- •epidural catheter insertion within previous 12 hours
- •ICU admission > 2 weeks
- •receipt of > 2 doses of LMWH while in ICU or in hospital within 7 days prior to study enrolment
- •active bleeding; platelet count < 50 x 109/L
- •INR or aPTT > 2 times the upper limit of normal
- •need for therapeutic anticoagulation; previous adverse reaction to heparin based products
- •contraindication to blood product transfusion
- •pregnant or lactating women
- •life expectancy < 2 weeks or receiving palliative care
- •previous enrolment in current study.
结局指标
主要结局
Determine the rate of patient enrollment into this study within the 24 month allotted time frame of recruitment
时间窗: 24 months
This is a pilot feasibility study
次要结局
- Record incidence of major bleeding episodes using the HEME bleeding assessment tool(Daily until ICU discharge or a maximum of the first 10 days of ICU stay, whichever is less)
- Record incidence of VTE(Daily until ICU discharge or a maximum of the first 10 days of ICU stay, whichever is less)
- Measure bioaccumulation of Enoxaparin, if any, defined as at least one trough anti-Xa level measuring > 0.4 IU/mL(ICU stay until discharge or a maximum of the first 10 days of ICU stay, whichever is less)