The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients. a Phase 2, Randomized, Doble Blind, Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Major bleeding
研究概览
简要总结
the risk of bleeding may be greater than the benefit of antithrombotic protection when prophylactically anticoagulating a patient with a lower limb fracture and advanced CKD.
The primary objective was to evaluate the risk major bleeding in patients with lower limb fractures and advance CKD. The secondary objectives were to assess major bleeding in patients with lower limb fractures in CKD stage 4 and 5, thrombosis, death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Blinding was achieved by shielding the patients from seeing the preparation of the study drug and having unblinded study personnel not involved in any study outcome assessments responsible for preparing and administering the study treatment.
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
- •lower limb fracture before surgery
- •CKD (chonic kidney disease)
排除标准
- •<18 years old
- •kidney transplant
- •hospital stay <48 hours
- •had received any anticoagulant before random assignment to a patient group
- •had missing data that would render analysis incomplete
研究组 & 干预措施
Anticoagulation
The intervention drug of interest was prophylactic anticoagulation with enoxaparin 1mg/kg of ideal body weight subcutaneous every 24 hours in patients with eGFR <30ml/min/1.73m2 (REF); enoxaparin will continue till surgery, any mandatory adverse event, dead or discharge. Enoxaparin or placebo started on admission to the trial, stopped 12 hours before surgery and all patients received prophylaxis anticoagulation restarted 6 to 12 hours postoperatively according to orthopedic surgeon practices. We choose enoxaparin, a low molecular weight heparin according to the ACCP guidelines as the gold standard for VTE prophylaxis in orthopedic patients
干预措施: Enoxaparin (Drug)
No anticoagulation
The no anticoagulation strategy was considerate the control group, we choose as placebo a bolus of 10ml normal saline 0.9%, was prepared and administered behind a screen or curtain, and the drug was administered through normal IV tubes
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Major bleeding
时间窗: From date of randomization until the date of first documented major bleeding or death from any cause, whichever came first up to 20 days. From date of randomization until surgery. Pre-intervention/procedure/surgery.
Number of Participants with Major bleeding were defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria (Schulman S). Defined as the composed event of: 1- Fatal bleeding, and/or; 2- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3- Bleeding causing a fall in hemoglobin level of 2.0 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells
次要结局
- Thrombosis(From date of randomization until the date of first documented thrombosis, or date of death from any cause, whichever came first, assessed from date of randomization until surgery up to 20 days. Pre-intervention/procedure/surgery.)
- Dead(through study completion, an average of 3 weeks)
- number of transfusions(From date of randomization until the date of first documented transfusions and number of transfusions. Pre-intervention/procedure/surgery.)
- acute kidney injury(From date of randomization until the date of first documented acute kidney injury up to 20 days. From date of randomization until surgery. Pre-intervention/procedure/surgery.)
- hospitalization days(number of days in hospital. through study completion, an average of 3 weeks)
研究者
Jonathan Samuel Chavez Iñiguez
Head of nephrology
Hospital Civil de Guadalajara