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Trial record 6 of 10 for:    "Collagen Disease" | "Rivaroxaban"

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

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ClinicalTrials.gov Identifier: NCT02085824
Recruitment Status : Unknown
Verified March 2014 by Marcin Wasko MD PhD, Centre of Postgraduate Medical Education.
Recruitment status was:  Recruiting
First Posted : March 13, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Marcin Wasko MD PhD, Centre of Postgraduate Medical Education

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Blood Loss Drug: Enoxaparin Drug: rivaroxaban Drug: dabigatran Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
Study Start Date : July 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: enoxaparin
enoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days
Drug: Enoxaparin
Experimental: rivaroxaban
rivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery
Drug: rivaroxaban
Experimental: dabigatran
dabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery
Drug: dabigatran



Primary Outcome Measures :
  1. Total blood loss by the 3rd postoperative day [ Time Frame: 3rd day postoperatively ]
    Measured for each individual. Measured according to the formula described by Nadler, Hidalgo and Bloch (Prediction of blood volume in normal human adults. Surgery 1962;51:224-32).


Secondary Outcome Measures :
  1. Drop in the haemoglobin value between 3rd day postop and preoperative [ Time Frame: 3rd day postopertively ]
    Difference between haemoglobin on the 3rd postopertive day and day before operation

  2. Wound healing disturbances according to the definition of Centers for Disease Control and Prevention [ Time Frame: 3 months postoperatively ]
    Wound healing disturbances - diagnosis to be made according to the definition of Centers for Disease Control and Prevention (Mangram, Horan, Pearson, Silver and Jarvis. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • inflammatory arthropathies
  • liver disorders
  • neoplastic conditions
  • clotting disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085824


Contacts
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Contact: Marcin K Wasko, M.D., Ph.D. +48227794031 ext 384 m.wasko@cmkp.edu.pl

Locations
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Poland
Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education Recruiting
Otwock, Woj. Mazowieckie, Poland, 05-400
Principal Investigator: Marcin K Wasko, M.D., Ph.D.         
Sponsors and Collaborators
Centre of Postgraduate Medical Education
Investigators
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Principal Investigator: Marcin K Wasko, M.D., Ph.D. The Medical Centre of Postgraduate Education, Department of Orthopaedics and Inflammatory Disorders of Locomotor System

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Responsible Party: Marcin Wasko MD PhD, Dr Marcin Wasko MD PhD, Centre of Postgraduate Medical Education
ClinicalTrials.gov Identifier: NCT02085824     History of Changes
Other Study ID Numbers: CPX-2012
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
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Rheumatic Diseases
Rivaroxaban
Osteoarthritis
Hemorrhage
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Dabigatran
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants