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Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

NCT ID: NCT01446887

Last Updated: 2011-10-12

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

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-02-28

Brief Summary

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Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A randomized double-blind study was conducted to determine whether prophylactic anticoagulation was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator also used logistic regression analysis with variable selection for obtaining the prediction model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical compression, duration of surgery). THA with short duration of surgery did not require prophylactic anticoagulation.

Detailed Description

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Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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non-prophylactic anticoagulation

without prophylactic anticoagulation

Group Type NO_INTERVENTION

No interventions assigned to this group

prophylactic anticoagulation

prophylactic anticoagulation by rivaroxaban

Group Type EXPERIMENTAL

prophylactic anticoagulation

Intervention Type OTHER

prophylactic anticoagulation by rivaroxaban

Interventions

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prophylactic anticoagulation

prophylactic anticoagulation by rivaroxaban

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primary total hip arthroplasty

Exclusion Criteria

* Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded.
* Coagulation related disease and cancer were excluded either.
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JIANG Qing

OTHER

Sponsor Role lead

Responsible Party

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JIANG Qing

Director, The Center of Diagnosis and Treatment for Joint Disease

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Center of Diagnosis and Treatment for Joint Disease, Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NJDVTS

Identifier Type: -

Identifier Source: org_study_id