Therapeutic Anticoagulation Strategy for Acute Chest Syndrome

Anemia Clinical Trial

— TASC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580773
• Other study ID #: AOR14068
• Status: Completed
• Phase: Phase 3
• Start date: December 16, 2016
• Est. completion date: September 15, 2021

Study information

• Verified date: April 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 15, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Major sickle cell syndrome (SS, SC, Sß)
• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Prophylactic anticoagulation ( INNOHEP®)
subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a prophylactic dose (4500 UI/day)
• Curative anticoagulation ( INNOHEP®)
subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a curative dose (175 UI/kg/day for 7 days)

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	LEO Pharma

Country where clinical trial is conducted

France, 

References & Publications (2)

Mekontso Dessap A, Deux JF, Abidi N, Lavenu-Bombled C, Melica G, Renaud B, Godeau B, Adnot S, Brochard L, Brun-Buisson C, Galacteros F, Rahmouni A, Habibi A, Maitre B. Pulmonary artery thrombosis during acute chest syndrome in sickle cell disease. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1022-9. doi: 10.1164/rccm.201105-0783OC. — View Citation

Qari MH, Aljaouni SK, Alardawi MS, Fatani H, Alsayes FM, Zografos P, Alsaigh M, Alalfi A, Alamin M, Gadi A, Mousa SA. Reduction of painful vaso-occlusive crisis of sickle cell anaemia by tinzaparin in a double-blind randomized trial. Thromb Haemost. 2007 Aug;98(2):392-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main efficacy endpoint is time to ACS resolution	The delay between randomization and ACS resolution	up to 15 days
Primary	Number of major bleedings		up to 15 days
Secondary	Number of complicated ACS		up to 15 days
Secondary	Blood volume exchanged		up to 15 days
Secondary	Cumulative dose of opioids		up to 15 days
Secondary	Hospital mortality		up to 15 days
Secondary	Duration of hospital stay		up to 15 days
Secondary	Number of non-major bleedings		up to 15 days
Secondary	Number of readmissions and thromboembolic events within 6 months		at 6 months