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Therapeutic Anticoagulation Strategy for Acute Chest Syndrome (TASC)

Primary Purpose

Anemia, Sickle Cell, Acute Chest Syndrome

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Prophylactic anticoagulation ( INNOHEP®)
Curative anticoagulation ( INNOHEP®)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Sickle cell disease, Anemia, Rare disease, Reanimation, Prophylactic anticoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henri Mondor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Prophylactic anticoagulation

Curative anticoagulation

Arm Description

Outcomes

Primary Outcome Measures

The main efficacy endpoint is time to ACS resolution
The delay between randomization and ACS resolution
Number of major bleedings

Secondary Outcome Measures

Number of complicated ACS
Blood volume exchanged
Cumulative dose of opioids
Hospital mortality
Duration of hospital stay
Number of non-major bleedings
Number of readmissions and thromboembolic events within 6 months

Full Information

First Posted
October 5, 2015
Last Updated
October 18, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02580773
Brief Title
Therapeutic Anticoagulation Strategy for Acute Chest Syndrome
Acronym
TASC
Official Title
A Prospective, Randomized, Double-blind, Placebo Controlled, Multi-national Study of Therapeutic Anticoagulation Strategy for Acute Chest Syndrome in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 16, 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Sickle Cell, Acute Chest Syndrome, Low-Molecular-Weight Heparin
Keywords
Sickle cell disease, Anemia, Rare disease, Reanimation, Prophylactic anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic anticoagulation
Arm Type
Other
Arm Title
Curative anticoagulation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Prophylactic anticoagulation ( INNOHEP®)
Intervention Description
subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a prophylactic dose (4500 UI/day)
Intervention Type
Drug
Intervention Name(s)
Curative anticoagulation ( INNOHEP®)
Intervention Description
subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a curative dose (175 UI/kg/day for 7 days)
Primary Outcome Measure Information:
Title
The main efficacy endpoint is time to ACS resolution
Description
The delay between randomization and ACS resolution
Time Frame
up to 15 days
Title
Number of major bleedings
Time Frame
up to 15 days
Secondary Outcome Measure Information:
Title
Number of complicated ACS
Time Frame
up to 15 days
Title
Blood volume exchanged
Time Frame
up to 15 days
Title
Cumulative dose of opioids
Time Frame
up to 15 days
Title
Hospital mortality
Time Frame
up to 15 days
Title
Duration of hospital stay
Time Frame
up to 15 days
Title
Number of non-major bleedings
Time Frame
up to 15 days
Title
Number of readmissions and thromboembolic events within 6 months
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armand Mekontso Dessap, MD, PhD
Phone
(0)149812394
Ext
+33
Email
armand.dessap@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Maitre, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Armand Mekontso Dessap, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armand Mekontso Dessap, MD, PhD
Phone
(0)149812394
Ext
+33
Email
armand.dessap@aphp.fr
First Name & Middle Initial & Last Name & Degree
Bernard Maitre, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17721622
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.
Results Reference
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PubMed Identifier
21836136
Citation
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.
Results Reference
background

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Therapeutic Anticoagulation Strategy for Acute Chest Syndrome

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