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

December 7, 2012 updated by: Pål Borgen, MD, Martina Hansen's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Gjettum
      • Sandvika, Gjettum, Norway, 1346
        • Martina Hansen's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dalteparin 5000IU s.c.
5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty
Drug: dalteparin 5000 IU s.c.
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.
Other Names:
  • Fragmin
Placebo Comparator: 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
Drug: dalteparin 5000 IU s.c.
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.
Other Names:
  • Fragmin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martina Hansen's Hospital

Collaborators

Oslo University Hospital

Investigators

  • Study Chair: Olav Reikeras, MD, Phd, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Estimate)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK Sør-øst s-08012d

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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