Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.

NCT ID: NCT02085824

Last Updated: 2014-03-14

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).

Detailed Description

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Conditions

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Hip Osteoarthritis Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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enoxaparin

enoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days

Group Type EXPERIMENTAL

Enoxaparin

Intervention Type DRUG

rivaroxaban

rivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery

Group Type EXPERIMENTAL

rivaroxaban

Intervention Type DRUG

dabigatran

dabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery

Group Type EXPERIMENTAL

dabigatran

Intervention Type DRUG

Interventions

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Enoxaparin

Intervention Type DRUG

rivaroxaban

Intervention Type DRUG

dabigatran

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* primary, end-stage hip osteoarthritis requiring total hip arthroplasty

Exclusion Criteria

* inflammatory arthropathies
* liver disorders
* neoplastic conditions
* clotting disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre of Postgraduate Medical Education

OTHER

Sponsor Role lead

Responsible Party

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Marcin Wasko MD PhD

Dr Marcin Wasko MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcin K Wasko, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Medical Centre of Postgraduate Education, Department of Orthopaedics and Inflammatory Disorders of Locomotor System

Locations

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Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education

Otwock, Woj. Mazowieckie, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marcin K Wasko, M.D., Ph.D.

Role: CONTACT

+48227794031 ext. 384

Other Identifiers

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CPX-2012

Identifier Type: -

Identifier Source: org_study_id

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