A Prospective, Randomized, Double-blind, Placebo Controlled, Multi-national Study of Therapeutic Anticoagulation Strategy for Acute Chest Syndrome in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Number of major bleedings
研究概览
简要总结
Acute Chest Syndrome (ACS) is a pulmonary complication of sickle cell disease (SCD) representing the leading cause of death and the second cause of hospitalization among adult patients. Pulmonary vaso-occlusion is one of the main pathophysiologic hypotheses during ACS. Our hypothesis is that therapeutic anticoagulation may reduce the severity of ACS via the alleviation of pulmonary thrombosis. The main objective of this prospective, randomized, double-blind study is to test the efficacy and safety of a curative anticoagulation strategy during ACS. The main efficacy endpoint is time to ACS resolution. The main safety endpoint is number of major bleedings.
A thoracic CT scan will be performed to check for pulmonary artery thrombosis. If the CT scan is positive (thrombosis within a large elastic artery), the patient will not be randomized and will be treated with a curative anticoagulation. If the CT scan is negative, the patient will be randomized to receive subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) either at a curative dose (175 Unit International (UI)/kg/day for 7 days) or at a prophylactic dose (4500 UI/day).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Major sickle cell syndrome (SS, SC, Sβ)
- •ACS defined by the association of a new infiltrate on chest X-ray or CT scan and a respiratory symptom or abnormal chest auscultation
- •Written, informed consent
排除标准
- •Pregnancy, post-partum
- •Iodine allergy
- •Extreme weight (<40 kg or > 100 kg)
- •Moderate to severe renal insufficiency
- •Moya-moya disease
- •Symptomatic cerebral aneurysm
- •Major transfusional risk
- •Uncontrolled severe retinopathy
- •All other contra-indications to curative anti-coagulation by tinzaparin.
研究组 & 干预措施
Prophylactic anticoagulation
干预措施: Prophylactic anticoagulation ( INNOHEP®) (Drug)
Curative anticoagulation
干预措施: Curative anticoagulation ( INNOHEP®) (Drug)
结局指标
主要结局
Number of major bleedings
时间窗: up to 15 days
The main efficacy endpoint is time to ACS resolution
时间窗: up to 15 days
The delay between randomization and ACS resolution
次要结局
- Blood volume exchanged(up to 15 days)
- Cumulative dose of opioids(up to 15 days)
- Duration of hospital stay(up to 15 days)
- Number of non-major bleedings(up to 15 days)
- Hospital mortality(up to 15 days)
- Number of complicated ACS(up to 15 days)
- Number of readmissions and thromboembolic events within 6 months(at 6 months)