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Therapeutic Anticoagulation Strategy for Acute Chest Syndrome (TASC)

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ClinicalTrials.gov Identifier: NCT02580773
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).


Condition or disease Intervention/treatment Phase
Anemia Sickle Cell Acute Chest Syndrome Low-Molecular-Weight Heparin Drug: Prophylactic anticoagulation ( INNOHEP®) Drug: Curative anticoagulation ( INNOHEP®) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Placebo Controlled, Multi-national Study of Therapeutic Anticoagulation Strategy for Acute Chest Syndrome in Adults
Actual Study Start Date : December 16, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Prophylactic anticoagulation Drug: Prophylactic anticoagulation ( INNOHEP®)
subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a prophylactic dose (4500 UI/day)

Experimental: Curative anticoagulation Drug: Curative anticoagulation ( INNOHEP®)
subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a curative dose (175 UI/kg/day for 7 days)




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580773


Contacts
Contact: Armand Mekontso Dessap, MD, PhD (0)149812394 ext +33 armand.dessap@aphp.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Armand Mekontso Dessap, MD, PhD    (0)149812394 ext +33    armand.dessap@aphp.fr   
Contact: Bernard Maitre, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
LEO Pharma
Investigators
Principal Investigator: Bernard Maitre, MD, PhD Assistance Publique - Hôpitaux de Paris
Study Chair: Armand Mekontso Dessap, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02580773     History of Changes
Other Study ID Numbers: AOR14068
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sickle cell disease
Anemia
Rare disease
Reanimation
Prophylactic anticoagulation

Additional relevant MeSH terms:
Syndrome
Acute Chest Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Heparin, Low-Molecular-Weight
Dalteparin
Tinzaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action