Therapeutic Anticoagulation Strategy for Acute Chest Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-16

Study Completion Date

2021-09-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Anemia Sickle Cell Acute Chest Syndrome Low-Molecular-Weight Heparin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prophylactic anticoagulation

Group Type OTHER

Prophylactic anticoagulation ( INNOHEP®)

Intervention Type DRUG

subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a prophylactic dose (4500 UI/day)

Curative anticoagulation

Group Type EXPERIMENTAL

Curative anticoagulation ( INNOHEP®)

Intervention Type DRUG

subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a curative dose (175 UI/kg/day for 7 days)

Interventions

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Prophylactic anticoagulation ( INNOHEP®)

subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a prophylactic dose (4500 UI/day)

Intervention Type DRUG

Curative anticoagulation ( INNOHEP®)

subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a curative dose (175 UI/kg/day for 7 days)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No