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NCT00796692

Nadroparin for the Initial Treatment of Pulmonary Thromboembolism

Last Updated: 2008-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2006-02-28

Brief Summary

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Detailed Description

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Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard, unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are available on the evaluation of body weight adjusted LWMH and standard UFH for the initial treatment of PTE in Chinese population.

The aim of this study is to determine whether body weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of patients with objectively documented PTE.

An open-label, adjudicator-blinded, randomized controlled trial of patients with symptomatic non-massive PTE from 37 major hospitals in China is conducted . Intravenous UFH was administered received an initial bolus dose of 80 IU/kg, followed by a continuous infusion at an initial rate of 18 IU/kg /hour. The dose was subsequently adjusted by activated partial thromboplastin time (APTT) monitoring. LMWH (nadroparin) was administered subcutaneously at a dose of 86 anti-factor Xa IU/kg every 12 hours.

Both treatments were overlapped with at least 3 months of warfarin therapy. Main outcome measures were combined end point of clinical effect, image improvement,Recurrent venous thromboembolism(VTE), major bleeding, and death within 14 days and 3 months of randomization.

Conditions

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Pulmonary Embolism Thromboembolism Vascular Diseases Thrombosis

Keywords

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Heparin Low molecular weight heparin Safety Efficacy Cost effective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 2

Low molecular weight heparin

Group Type EXPERIMENTAL

Nadroparin

Intervention Type DRUG

LMWH is given with a weight adjusted dose of 86 international anti-factor Xa units of nadroparin (Fraxiparine) per kilogram of body weight(86 anti-factor Xa IU/kg) subcutaneously every 12 hours,which will be used at least 5-7 days.

Group 1

Unfractionated heparin(UFH)

Group Type ACTIVE_COMPARATOR

Unfractionated heparin(UFH)

Intervention Type DRUG

UFH is received with an initial bolus dose of 80 IU per kilogram, followed by a continuous intravenous infusion at an initial rate of 18 IU per kilogram per hour. The dose is subsequently adjusted so that the activated partial thromboplastin time (APTT) would be 1.5 to 2.5 times the control value in normal subjects. The tests are performed 4 hours after the start of treatment, whenever a sub-therapeutic APTT had been measured after a dose adjustment, and otherwise daily.UFH will be used at least 5-7 days.

Interventions

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Nadroparin

Intervention Type DRUG

Unfractionated heparin(UFH)

Intervention Type DRUG

Other Intervention Names

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Low moleculor weight hepatin Standard Unfractionated heparin

Eligibility Criteria

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Inclusion Criteria

* 18 to 75 years of age
* Symptomatic non massive PTE confirmed either by a high probability ventilation-perfusion lung scanning (V/Q scan) or by the presence of intraluminal filling defect on spiral computed tomographic pulmonary angiography (CTPA)
* Haemodynamic stabile, anatomic obstruction no more than 2 lobes on CTPA, or defect no more than 7 segments on V/Q scan,and normal right ventricular function
* Symptoms within 15 days
* Written informed consent obtained before randomization.

Exclusion Criteria

* Unfractioned heparin anticoagulation for more than 36 hours prior enrollment,
* Massive PTE or sub-massive PTE requiring thrombolytic therapy or pulmonary embolectomy; Active bleeding or disorders contraindicating anticoagulant therapy
* Chronic thromboembolism pulmonary hypertension(CTEPH) without evidence of recent episode; Severe hepatic or renal failure
* Allergy to heparin, other components of Tinzaparin or acenocoumarol,
* Pregnant status;a life expectancy of less than 3 months;
* Previous thrombocytopenia induced by heparin
* Thrombocytopenia \< 100000/mm3,

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Beijing Institute of Respiratory Medicine

Principal Investigators

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Chen WANG, Prof

Role: PRINCIPAL_INVESTIGATOR

Beijing Institute of Respiratory Medicine,Beijing Chao Yang Hospital

Locations

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