Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of dalteparin vs unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized acutely ill medical patients.

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Detailed Description

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The study was prematurely discontinued due to delay in overall study start-up and inability to meet pre-defined protocol recruitment milestones on June 30th, 2008. There were no safety concerns regarding the study in the decision to terminate the trial.

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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B

Group Type ACTIVE_COMPARATOR

Unfractionated heparin

Intervention Type DRUG

Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.

A

Group Type EXPERIMENTAL

Dalteparin (Fragmin)

Intervention Type DRUG

Dalteparin 5000 IU once daily subcutaneously for 6-14 days.

Interventions

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Dalteparin (Fragmin)

Dalteparin 5000 IU once daily subcutaneously for 6-14 days.

Intervention Type DRUG

Unfractionated heparin

Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged greater than or equal to 18 years
* Acute medical condition with a projected hospitalization of greater than or equal to 4 days and had less than or equal to 3 days of prior immobilization for more than two thirds of the day
* Acute congestive heart failure Class III-IV per NHYA/ Acute respiratory failure not requiring mechanical ventilation or Both
* Acute infection without septic shock/ Acute episode of inflammatory bowel disease/ Acute rheumatologic disorders/ Acute lumbar pain or sciatica or vertebral compression with at least one risk factor for VTE

Exclusion Criteria

* Contraindications to use of anticoagulants
* Active bleeding or abnormal coagulation tests
* Recent (less than 1 month) head injury, hemorrhagic stroke, cerebral tumor or intracranial aneurysm or ischemic stroke within the last month.
* Major surgical or invasive procedure within the last month resulting in ongoing convalescence
* Lumbar or spinal puncture within last 48 hours
* S creatinine levels more than 2
* On inotropic agents

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No