Clinical Trial: Therapeutic Anticoagulation Strategy for Acute Chest Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Prospective, Randomized, Double-blind, Placebo Controlled, Multi-national Study of Therapeutic Anticoagulation Strategy for Acute Chest Syndrome in Adults

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 (UI)/kg/day for 7 days) or at a prophylactic dose (4500 UI/day).


Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome:

  • The main efficacy endpoint is time to ACS resolution [ Time Frame: up to 15 days ]
    The delay between randomization and ACS resolution
  • Number of major bleedings [ Time Frame: up to 15 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: October 5, 2015
Date Started: November 2015
Date Completion: November 2017
Last Updated: October 18, 2015
Last Verified: September 2015