TASC: Therapeutic Anticoagulation Strategy for Acute Chest Syndrome

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02580773
• Collaborator: LEO Pharma (Industry)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.5
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Dec 16, 2016
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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)

Outcome Measures

Primary Outcome Measures

1. The main efficacy endpoint is time to ACS resolution [up to 15 days]

   The delay between randomization and ACS resolution

2. Number of major bleedings [up to 15 days]

Secondary Outcome Measures

1. Number of complicated ACS [up to 15 days]

2. Blood volume exchanged [up to 15 days]

3. Cumulative dose of opioids [up to 15 days]

4. Hospital mortality [up to 15 days]

5. Duration of hospital stay [up to 15 days]

6. Number of non-major bleedings [up to 15 days]

7. Number of readmissions and thromboembolic events within 6 months [at 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henri Mondor Hospital	Creteil		France	94010

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02580773
• Other Study ID Numbers: AOR14068
• First Posted: Oct 20, 2015
• Last Update Posted: Oct 19, 2017
• Last Verified: Oct 1, 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: Acute Chest Syndrome; Syndrome; Tinzaparin

Study Results

No Results Posted as of Oct 19, 2017