Prophylactic ANTicoagulation With HEparine in Critically Ill Patients With Renal Impairment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,111
- 试验地点
- 15
- 主要终点
- Incidence of hemorrhagic and thrombotic events in patients with renal failure in intensive care receiving heparin thromboprophylaxis
研究概览
简要总结
Intensive care patients have an increased risk of venous thromboembolic events (deep vein thrombosis (DVT) and pulmonary embolism (PE)) due to the presence of general risk factors for thrombosis (age, immobilization, obesity, prothrombotic history, etc.), but also risk factors specifically related to their stay in intensive care (sepsis, vasopressors, organ failure, mechanical ventilation, sedation, renal failure, central venous catheters). In addition, these same patients also have an increased risk of hemorrhagic events, mainly associated with coagulation disorders and thrombocytopenia.
Given this increased risk of thrombosis, it is recommended that heparin thromboprophylaxis be used in intensive care patients in the absence of contraindications.
In current practice, when faced with a patient with impaired renal function, there is significant heterogeneity in the prescription of thromboprophylaxis between centers and intensive care physicians: some will use enoxaparin, dalteparin, or tinzaparin regardless of renal function, while others will use subcutaneous calciparin or IVSE UFH.
The PANTHER study is a prospective, multicenter, observational study that aims to evaluate the safety and efficacy of heparin thromboprophylaxis in critically ill patients with renal failure. The goal is to assess whether there is a difference in bleeding risk and thromboprophylaxis efficacy depending on the molecule used.
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
- •Presence of impaired renal function (one of the two criteria must be met, both criteria may be met):
- •Glomerular filtration rate (GFR) <30ml/min/1.7m² according to the MDRD or CKD-EPI formula.
- •Acute renal failure (observed or presumed increase in creatinine in the last 7 days) KDIGO stage 3 (creatinine ≥3 times baseline creatinine or ≥354 µmol/L (4 mg/dL) or urine output <0.3 mL/kg/h for ≥24 hours or initiation of extrarenal clearance or anuria for ≥12 hours)
- •- Expected length of stay in intensive care ≥48 hours
排除标准
- •Age ≤ 18 years
- •Long-term dialysis patient
- •Current or recent hemorrhage during this hospitalization
- •Patient receiving curative anticoagulation or treated long-term prior to admission with curative anticoagulation.
- •Thrombosis present on admission
研究组 & 干预措施
patient with impaired renal function in intensive care
结局指标
主要结局
Incidence of hemorrhagic and thrombotic events in patients with renal failure in intensive care receiving heparin thromboprophylaxis
时间窗: Day 1 to Day 28
Incidence of hemorrhagic and thrombotic events was evaluated by occurrence of major bleeding and occurrence of a venous thromboembolic event
次要结局
未报告次要终点