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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
198
subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a prophylactic dose (4500 UI/day)
subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a curative dose (175 UI/kg/day for 7 days)
Henri Mondor Hospital
Créteil, France
The main efficacy endpoint is time to ACS resolution
The delay between randomization and ACS resolution
Time frame: up to 15 days
Number of major bleedings
Time frame: up to 15 days
Number of complicated ACS
Time frame: up to 15 days
Blood volume exchanged
Time frame: up to 15 days
Cumulative dose of opioids
Time frame: up to 15 days
Hospital mortality
Time frame: up to 15 days
Duration of hospital stay
Time frame: up to 15 days
Number of non-major bleedings
Time frame: up to 15 days
Number of readmissions and thromboembolic events within 6 months
Time frame: at 6 months
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