Preoperative Versus Postoperative Start With Thromboprophylaxis in THA (Total Hip Arthroplasty)

Study Overview
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Brief Summary
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The purpose of this study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight Heparin) is initiated before or after surgery.

Official Title
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A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin

Conditions
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Arthritis of the Hip, Transfusion Related Complications, Infection, Wound Discharge

Intervention / Treatment
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* Drug: dalteparin 5000 IU s.c.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -patients 50 years or older undergoing cemented total hip arthroplasty for primary osteoarthritis Exclusion Criteria: allergy to Low-Molecular-Weight -Heparin bleeding disorders renal failure hepatic disease active treatment for malignancy history of deep venous thrombosis or pulmonary embolism major operations,trauma,stroke or cardiac infarction the last 3 months before surgery.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dalteparin 5000IU s.c.<br>5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty | Drug: dalteparin 5000 IU s.c.<br>* All patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35.<br>* Other names: Fragmin;|
| Placebo Comparator: saline<br>Syringes of Saline with the same volume as in the dalteparin injections are injected the evenings before total hip arthroplasty. Dalteparin 5000IU are injected 6 hours after surgery and the concomitant 33 days | Drug: dalteparin 5000 IU s.c.<br>* All patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35.<br>* Other names: Fragmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total blood loss | measured blood loss during surgery and in wound drains | during and after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion requirements | number of units packed red blood cells | during and after surgery | 
| incidence of bleeding events | excessive bleeding, wound hematoma, wound secretion, other bleeding events | during and after surgery | 
| other complications | all other complications related to surgery | during and after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cemented total hip arthroplasty, blood loss, wound discharge, thromboprophylaxis, biomarkers