Ignite Creation Date:
2024-05-06 @ 7:42 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02580773
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2015-10-05
Brief Title:
Therapeutic Anticoagulation Strategy for Acute Chest Syndrome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Prospective Randomized Double-blind Placebo Controlled Multi-national Study of Therapeutic Anticoagulation Strategy for Acute Chest Syndrome in Adults
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TASC
Brief Summary:
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 UIkgday for 7 days or at a prophylactic dose 4500 UIday
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 UIkgday for 7 days or at a prophylactic dose 4500 UIday
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None