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

Information source: Martina Hansen's Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis of the Hip; Transfusion Related Complications; Infection; Wound Discharge

Intervention: dalteparin 5000 IU s.c. (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Martina Hansen's Hospital

Official(s) and/or principal investigator(s):
Olav Reikeras, MD, Phd, Study Chair, Affiliation: Oslo University Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: total blood loss

Secondary outcome:

transfusion requirements

incidence of bleeding events

other complications

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Martina Hansen's Hospital, Sandvika, Gjettum 1346, Norway
Additional Information

Starting date: January 2008
Last updated: December 7, 2012

Page last updated: August 20, 2015

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