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NCT Number: NCT02580773

Therapeutic Anticoagulation Strategy for Acute Chest Syndrome

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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Key information

Conditions

Anemia Acute Chest Syndrome Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Low-Molecular-Weight Heparin Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Respiration Disorders Respiratory Tract Diseases Sickle Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henri Mondor Hospital

Créteil, 94010, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Main 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.

Treatment and study plan

Prophylactic anticoagulation ( INNOHEP®)

Drug

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

Curative anticoagulation ( INNOHEP®)

Drug

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

Primary outcomes

  1. The main efficacy endpoint is time to ACS resolution

    Time frame: up to 15 days

    The delay between randomization and ACS resolution

  2. Number of major bleedings

    Time frame: up to 15 days

Secondary outcomes

  1. Number of complicated ACS

    Time frame: up to 15 days

  2. Blood volume exchanged

    Time frame: up to 15 days

  3. Cumulative dose of opioids

    Time frame: up to 15 days

  4. Hospital mortality

    Time frame: up to 15 days

  5. Duration of hospital stay

    Time frame: up to 15 days

  6. Number of non-major bleedings

    Time frame: up to 15 days

  7. Number of readmissions and thromboembolic events within 6 months

    Time frame: at 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • LEO Pharma

Registry information

Official study title

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

Acronym: TASC

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2015
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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