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

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02085824
• Other study ID #: CPX-2012
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2014
• Last updated: March 13, 2014
• Start date: July 2012
• Est. completion date: April 2014

Study information

• Verified date: March 2014
• Source: Medical Centre of Postgraduate Education, Poland
• Contact: Marcin K Wasko, M.D., Ph.D.
• Phone: +48227794031
• Email: m.wasko[@]cmkp.edu.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• inflammatory arthropathies

• liver disorders

• neoplastic conditions

• clotting disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage
• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• Enoxaparin

• rivaroxaban

• dabigatran

Locations

Country	Name	City	State
Poland	Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education	Otwock	Woj. Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre of Postgraduate Education, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Drop in the haemoglobin value between 3rd day postop and preoperative	Difference between haemoglobin on the 3rd postopertive day and day before operation	3rd day postopertively	No
Secondary	Wound healing disturbances according to the definition of Centers for Disease Control and Prevention	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)	3 months postoperatively	No