Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Hip Osteoarthritis Blood Loss||Drug: Enoxaparin Drug: rivaroxaban Drug: dabigatran||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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
- 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).
- 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
- 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)
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
|Contact: Marcin K Wasko, M.D., Ph.D.||+48227794031 ext firstname.lastname@example.org|
|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.|
|Principal Investigator:||Marcin K Wasko, M.D., Ph.D.||The Medical Centre of Postgraduate Education, Department of Orthopaedics and Inflammatory Disorders of Locomotor System|