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

Martina Hansen's Hospital1 site in 1 country80 target enrollmentJanuary 2008

ConditionsArthritis of the Hip Transfusion Related Complications Infection Wound Discharge

Interventionsdalteparin 5000 IU s.c.

Drugsdalteparin 5000 IU s.c.

Overview

Phase: Phase 4
Intervention: dalteparin 5000 IU s.c.
Conditions: Arthritis of the Hip
Sponsor: Martina Hansen's Hospital
Enrollment: 80
Locations: 1
Primary Endpoint: total blood loss
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

April 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Martina Hansen's Hospital

Responsible Party

Principal Investigator

Pål Borgen, MD

MD.

Martina Hansen's Hospital

Eligibility Criteria

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.

Arms & Interventions

dalteparin 5000IU s.c.

5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty

Intervention: dalteparin 5000 IU s.c.

saline

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

Intervention: dalteparin 5000 IU s.c.