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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enoxaparin | Experimental | enoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days |
|
| rivaroxaban | Experimental | rivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery |
|
| dabigatran | Experimental | dabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug |
| ||
| rivaroxaban |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Wound healing disturbances according to the definition of Centers for Disease Control and Prevention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcin K Wasko, M.D., Ph.D. | Contact | +48227794031 | 384 | m.wasko@cmkp.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Marcin K Wasko, M.D., Ph.D. | The Medical Centre of Postgraduate Education, Department of Orthopaedics and Inflammatory Disorders of Locomotor System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education | Recruiting | Otwock | Woj. Mazowieckie | 05-400 | Poland |
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|
| dabigatran | Drug |
|
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 |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D000069552 | Rivaroxaban |
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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