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

Primary Purpose

Hip Osteoarthritis, Blood Loss

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Enoxaparin
rivaroxaban
dabigatran
Sponsored by
Centre of Postgraduate Medical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

enoxaparin

rivaroxaban

dabigatran

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Drop in the haemoglobin value between 3rd day postop and preoperative
Difference between haemoglobin on the 3rd postopertive day and day before operation
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)

Full Information

First Posted
March 7, 2014
Last Updated
March 13, 2014
Sponsor
Centre of Postgraduate Medical Education
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1. Study Identification

Unique Protocol Identification Number
NCT02085824
Brief Title
Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
Official Title
Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Blood Loss

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
enoxaparin
Arm Type
Experimental
Arm Description
enoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days
Arm Title
rivaroxaban
Arm Type
Experimental
Arm Description
rivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery
Arm Title
dabigatran
Arm Type
Experimental
Arm Description
dabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Type
Drug
Intervention Name(s)
rivaroxaban
Intervention Type
Drug
Intervention Name(s)
dabigatran
Primary Outcome Measure Information:
Title
Total blood loss by the 3rd postoperative day
Description
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).
Time Frame
3rd day postoperatively
Secondary Outcome Measure Information:
Title
Drop in the haemoglobin value between 3rd day postop and preoperative
Description
Difference between haemoglobin on the 3rd postopertive day and day before operation
Time Frame
3rd day postopertively
Title
Wound healing disturbances according to the definition of Centers for Disease Control and Prevention
Description
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)
Time Frame
3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary, end-stage hip osteoarthritis requiring total hip arthroplasty Exclusion Criteria: inflammatory arthropathies liver disorders neoplastic conditions clotting disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcin K Wasko, M.D., Ph.D.
Phone
+48227794031
Ext
384
Email
m.wasko@cmkp.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin K Wasko, M.D., Ph.D.
Organizational Affiliation
The Medical Centre of Postgraduate Education, Department of Orthopaedics and Inflammatory Disorders of Locomotor System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education
City
Otwock
State/Province
Woj. Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcin K Wasko, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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