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EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
enoxaparin sodium
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism

Eligibility Criteria

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

Inclusion criteria: Recent immobilization ≤ 3 days Level 1 mobility patients who are ≥ 40 years of age with acute medical illness or acute exacerbation of chronic medical illness Level 2 mobility patients who are >75 yrs of age are ≥ 40 years of age and have a history of VTE (deep venous thrombosis or pulmonary embolism) are ≥ 40 years of age and have a baseline diagnosis of cancer (active cancer or history of cancer) Anticipated decreased level of mobility of 5 ± 2 days with a level of activity 1 and 2 at the time of study entry and likely to continue at a lower than pre-morbid activity level after the initial 5 ± 2 day period. PATIENTS DO NOT HAVE TO BE HOSPITALIZED IN ORDER TO BE INCLUDED IN THE STUDY.(Definition of decreased level of mobility: _Level 1:bed rest or sedentary patients _Level 2:level 1 with bathroom privileges) Presence of at least one of the following medical conditions: Heart Failure, NYHA class III and IV Class III : Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitationdyspnea, or anginal pain. Class IV : Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. Acute respiratory insufficiency Other acute medical conditions such as: Acute ischemic stroke, any territory, with an appropriate neuroradiologic (head CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke acute infection without septic shock acute rheumatic disorders active episode of inflammatory bowel disease active cancer defined as history of histologically or cytologically confirmed cancer in patients who are not candidates for debulking or curative intent surgery at study entry Any other acute medical illness or exacerbation of chronic medical illness resulting in clinically significant reduction in mobility as compared to premorbid level. Exclusion criteria: Women who are breastfeeding, pregnant or of childbearing age and not using medically acceptable effective contraception Patients with any evidence of an active bleeding disorder Contraindication to anticoagulation Major surgery within the previous 3 months Patients who have had spinal or epidural analgesia or lumbar puncture within the preceding 24 hours Known hypersensitivity to heparin, or LMWH, or pork derived products A documented previous episode of heparin-induced or LMWH induced thrombocytopenia and/or thrombosis (HIT, HAT, or HITTS) Patients who have taken part in another clinical trial within the previous thirty days Patients with a persistent renal failure. The patient's creatinine level must be less than the creatinine level per gender/age/weight. This will replace the calculated creatinine clearance Known or suspected severe anemia of unexplained cause considered clinically relevant by investigator Patients with prosthetic heart valves Patients with known cerebral metastases

Sites / Locations

  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

During double blind treatment : Cumulative occurrence of VTE assessed by ultrasound for all patients at 28±4 days after randomization (or earlier if symptomatic VTE) and/or V/Q lung scan for symptomatic patients ; Major hemorrhagic complications.

Secondary Outcome Measures

Occurrence of VTE between Day 1 and Day 90±10, Mortality at the end of Double-Blind Treatment, at 3 and 6 months
Minor plus major hemorrhagic complications during Double-Blind Treatment.

Full Information

First Posted
February 12, 2004
Last Updated
January 10, 2011
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00077753
Brief Title
EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization
Official Title
A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Primary objective: To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd Secondary objectives: To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes: Major and minor hemorrhage Heparin induced thrombocytopenia Serious adverse events To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
4726 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
enoxaparin sodium
Primary Outcome Measure Information:
Title
During double blind treatment : Cumulative occurrence of VTE assessed by ultrasound for all patients at 28±4 days after randomization (or earlier if symptomatic VTE) and/or V/Q lung scan for symptomatic patients ; Major hemorrhagic complications.
Secondary Outcome Measure Information:
Title
Occurrence of VTE between Day 1 and Day 90±10, Mortality at the end of Double-Blind Treatment, at 3 and 6 months
Title
Minor plus major hemorrhagic complications during Double-Blind Treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Recent immobilization ≤ 3 days Level 1 mobility patients who are ≥ 40 years of age with acute medical illness or acute exacerbation of chronic medical illness Level 2 mobility patients who are >75 yrs of age are ≥ 40 years of age and have a history of VTE (deep venous thrombosis or pulmonary embolism) are ≥ 40 years of age and have a baseline diagnosis of cancer (active cancer or history of cancer) Anticipated decreased level of mobility of 5 ± 2 days with a level of activity 1 and 2 at the time of study entry and likely to continue at a lower than pre-morbid activity level after the initial 5 ± 2 day period. PATIENTS DO NOT HAVE TO BE HOSPITALIZED IN ORDER TO BE INCLUDED IN THE STUDY.(Definition of decreased level of mobility: _Level 1:bed rest or sedentary patients _Level 2:level 1 with bathroom privileges) Presence of at least one of the following medical conditions: Heart Failure, NYHA class III and IV Class III : Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitationdyspnea, or anginal pain. Class IV : Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. Acute respiratory insufficiency Other acute medical conditions such as: Acute ischemic stroke, any territory, with an appropriate neuroradiologic (head CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke acute infection without septic shock acute rheumatic disorders active episode of inflammatory bowel disease active cancer defined as history of histologically or cytologically confirmed cancer in patients who are not candidates for debulking or curative intent surgery at study entry Any other acute medical illness or exacerbation of chronic medical illness resulting in clinically significant reduction in mobility as compared to premorbid level. Exclusion criteria: Women who are breastfeeding, pregnant or of childbearing age and not using medically acceptable effective contraception Patients with any evidence of an active bleeding disorder Contraindication to anticoagulation Major surgery within the previous 3 months Patients who have had spinal or epidural analgesia or lumbar puncture within the preceding 24 hours Known hypersensitivity to heparin, or LMWH, or pork derived products A documented previous episode of heparin-induced or LMWH induced thrombocytopenia and/or thrombosis (HIT, HAT, or HITTS) Patients who have taken part in another clinical trial within the previous thirty days Patients with a persistent renal failure. The patient's creatinine level must be less than the creatinine level per gender/age/weight. This will replace the calculated creatinine clearance Known or suspected severe anemia of unexplained cause considered clinically relevant by investigator Patients with prosthetic heart valves Patients with known cerebral metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Sagnard
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
Country
United States
Facility Name
Sanofi-Aventis
City
Buenos Aires
Country
Argentina
Facility Name
Sanofi-Aventis
City
North Ryde
Country
Australia
Facility Name
Sanofi-Aventis
City
Vienna
Country
Austria
Facility Name
Sanofi-Aventis
City
Brussels
Country
Belgium
Facility Name
Sanofi-Aventis
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis
City
Bogota
Country
Colombia
Facility Name
Sanofi-Aventis
City
Paris
Country
France
Facility Name
Sanofi-Aventis
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis
City
Mumbai
Country
India
Facility Name
Sanofi-Aventis
City
Natanya
Country
Israel
Facility Name
Sanofi-Aventis
City
Milan
Country
Italy
Facility Name
Sanofi-Aventis
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis
City
Warsaw
Country
Poland
Facility Name
Sanofi-Aventis
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis
City
Johannesburg
Country
South Africa
Facility Name
Sanofi-Aventis
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis
City
Megrine
Country
Tunisia
Facility Name
Sanofi-Aventis
City
Guildford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28762617
Citation
Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.
Results Reference
derived
PubMed Identifier
23117723
Citation
Turpie AG, Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Chen M, Yusen RD; EXCLAIM Investigators. Venous thromboembolism risk in ischemic stroke patients receiving extended-duration enoxaparin prophylaxis: results from the EXCLAIM study. Stroke. 2013 Jan;44(1):249-51. doi: 10.1161/STROKEAHA.112.659797. Epub 2012 Nov 1.
Results Reference
derived
PubMed Identifier
22863355
Citation
Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.
Results Reference
derived
PubMed Identifier
20621900
Citation
Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Nicol P, Vicaut E, Turpie AG, Yusen RD; EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study. Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial. Ann Intern Med. 2010 Jul 6;153(1):8-18. doi: 10.7326/0003-4819-153-1-201007060-00004.
Results Reference
derived

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EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization

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