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

NCT02085824 | Unknown

• 1 other identifier: CPX-2012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Hip Osteoarthritis; Blood Loss

Outcome Measures

Primary Outcomes (1)

• Total blood loss by the 3rd postoperative day

  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).

  3rd day postoperatively

Secondary Outcomes (2)

• Drop in the haemoglobin value between 3rd day postop and preoperative

  3rd day postopertively

• Wound healing disturbances according to the definition of Centers for Disease Control and Prevention

  3 months postoperatively

Study Arms (3)

enoxaparin

EXPERIMENTAL

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

Drug: Enoxaparin

rivaroxaban

EXPERIMENTAL

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

Drug: rivaroxaban

dabigatran

EXPERIMENTAL

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

Drug: dabigatran

Interventions

Enoxaparin DRUG

enoxaparin

rivaroxaban DRUG

rivaroxaban

dabigatran DRUG

dabigatran

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

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

Otwock, Woj. Mazowieckie, 05-400, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Hemorrhage

Interventions

Enoxaparin; Rivaroxaban; Dabigatran

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marcin K Wasko, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+48227794031; m.wasko@cmkp.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Marcin Wasko MD PhD

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 13, 2014
• Study Start: July 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 14, 2014

Record last verified: 2014-03

Locations

PL (1)