Study of the Bioaccumulation of Tinzaparin in Renally Impaired Patients When Given at Prophylactic Doses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Peak anti-Xa levels in patients with eGFR ≤ 30 mL/min/1.73 m2 receiving repeated daily doses of tinzaparin for VTE prophylaxis
研究概览
简要总结
The purpose of this study is to assess if accumulation of anti-Xa activity occurs after repeated daily administration of prophylactic doses of tinzaparin in patients with severe chronic kidney disease (CKD) requiring thromboprophylaxis for non-surgical conditions.
It is anticipated that tinzaparin used at a fixed dose for thromboprophylaxis in severe CKD patients (eGFR ≤ 30 ml/min /1.73 m2) at risk for venous thromboembolism (VTE) will not bioaccumulate at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level between day 2 or 3 and day 5.
详细描述
STUDY DESIGN :
Prospective, monocentric, open-label, single-arm, observational cohort study
Subjects hospitalized for non-surgical reasons by medical departments (ie Nephrology, Pneumology, Cardiology and Internal medicine) with chronic kidney disease (baseline eGFR ≤30 ml/min/1.73 m2) receiving tinzaparin prophylaxis at a dose of 3500 IU (or 4500 IU if BMI > 30kg/m2) once-daily.
Pharmacokinetic parameters: Peak anti-Xa analyses done after 2 (or 3), 5, and 8 days of treatment, and one trough anti-Xa analysis on day 5. The bioaccumulation of tinzaparin will be assessed by determining whether this dosing regimen is associated with an excessive increase in anti-Xa levels over the course of the treatment (see below for statistical analysis).
RECRUITMENT PROCESS:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age ≥ 18 years old
- •A prescription of prophylactic tinzaparin (3500 IU or 4500 IU) has been initiated by order of the treating physician
- •Patient admitted for medical reasons by one (but not limited to) of the following wards: nephrology, internal medicine, cardiology or pneumology
- •Chronic severe renal impairment defined as an eGFR ≤ 30 mL/min/1.73 m2 at the moment of prescription and when available, eGFR at baseline, ie ≤ 30 ml/min/1.73 m2 for the last 3 months
- •Estimated length of stay ≥ 5 days
- •Written informed consent obtained within at most 3 ± 1 hours after the second or third dose of tinzaparin.
排除标准
- •Super obese (Body-mass Index (BMI) > 50kg/m2)
- •Treatment with UFH, LMWH or oral factor Xa inhibitors <48h prior starting the first dose of tinzaparin
- •Prophylaxis with LMWH other than tinzaparin < 48h prior starting the first dose of tinzaparin
- •Prophylaxis with heparin < 12h prior starting the first dose of tinzaparin
- •Treatment with argatroban, bivalirudin < 24 hours prior starting the first dose of tinzaparin
- •Treatment with oral direct thrombin inhibitors, danaparoid, fondaparinux, or anti-vitamin K agents for < 7 days prior to starting the first dose of tinzaparin
- •Acute renal failure in an individual with baseline eGFR > 30 ml/min/1.73 m2
- •Prophylactic tinzaparin in use for more than 72h before inclusion
- •Severe liver insufficiency (Child- Pugh C)
- •Anuria or chronically dialysed patients (or eGFR < 5 ml/min/1.73 m2)
- •Participation in another study
研究组 & 干预措施
Tinzaparin
Hospitalized patients with chronic renal insufficiency (eGFR ≤ 30 mL/min/1.73 m2) at risk of VTE secondary to non-surgical reasons and receiving thromboprophylactic doses of tinzaparin 3500 or 4500 unit sub-cutaneous once daily.
干预措施: Tinzaparin (Drug)
结局指标
主要结局
Peak anti-Xa levels in patients with eGFR ≤ 30 mL/min/1.73 m2 receiving repeated daily doses of tinzaparin for VTE prophylaxis
时间窗: 4±1 hours after administration of tinzaparin on days 2 or 3, and 5.
To compare the anti-Xa levels between day 2 (or 3) and day 5 in order to assess if bioaccumulation occurs at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level.The anti-Xa levels will be measured 4±1 hours after administration, which corresponds to the maximal concentration (Cmax) of tinzaparin anti-Xa activity.
次要结局
- Peak anti-Xa levels in patients with eGFR ≤ 20 mL/min/1.73 m2 receiving repeated daily doses of tinzaparin for VTE prophylaxis(4±1 hours after administration of tinzaparin on days 2 or 3, and 5.)
- Peak anti-Xa levels in patients with eGFR ≤ 30 mL/min/1.73 m2 receiving repeated daily doses of tinzaparin for VTE prophylaxis(4±1 hours after administration of tinzaparin on days 2 or 3, and 8.)
- Anti-Xa trough level(On day 5)
研究者
Jean-Philippe Lafrance
MD., M.Sc., FRCPC
Maisonneuve-Rosemont Hospital