A Phase 3 interventional study of Prophylactic anticoagulation ( INNOHEP®) and Curative anticoagulation ( INNOHEP®) in Anemia, Sickle Cell and Acute Chest Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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).
37 studies on the registry are indexed under Acute Chest Syndrome; 11 are open to participants now.
This study's enrollment of 198 is above the median of 63 across 26 interventional studies indexed under Acute Chest Syndrome.
Browse Acute Chest Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Main Exclusion Criteria:
Drug: Prophylactic anticoagulation ( INNOHEP®)
Drug: Curative anticoagulation ( INNOHEP®)
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)
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
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris