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Completed

NCT Number: NCT01714297

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

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.

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Key information

Conditions

Arthritis of the Hip Hemorrhage Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Transfusion Related Complications Wound Discharge

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Martina Hansen's Hospital

Sandvika, Gjettum, 1346, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dalteparin 5000 IU s.c.

Drug

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

Primary outcomes

  1. total blood loss

    Time frame: during and after surgery

    measured blood loss during surgery and in wound drains

Secondary outcomes

  1. transfusion requirements

    Time frame: during and after surgery

    number of units packed red blood cells

  2. incidence of bleeding events

    Time frame: during and after surgery

    excessive bleeding, wound hematoma, wound secretion, other bleeding events

  3. other complications

    Time frame: during and after surgery

    all other complications related to surgery

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Oct 25, 2012
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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