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

Phase 4

Completed

• Conditions: Arthritis of the Hip; Transfusion Related Complications; Infection; Wound Discharge
• Interventions: Drug: dalteparin 5000 IU s.c.

• Registration Number: NCT01714297
• Lead Sponsor: Martina Hansen's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-06
• Study Completion: 2009-04
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-25
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-07
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dalteparin 5000IU s.c.	dalteparin 5000 IU s.c.	5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty
saline	dalteparin 5000 IU s.c.	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

Primary Outcome Measures

Name	Time	Method
total blood loss	during and after surgery	measured blood loss during surgery and in wound drains

Secondary Outcome Measures

Name	Time	Method
transfusion requirements	during and after surgery	number of units packed red blood cells
incidence of bleeding events	during and after surgery	excessive bleeding, wound hematoma, wound secretion, other bleeding events
other complications	during and after surgery	all other complications related to surgery

Trial Locations

Locations (1)

Martina Hansen's Hospital; 🇳🇴 Sandvika, Gjettum, Norway