Trial | NCT01714297  Report issue

Title

Preoperative Versus Postoperative Start With Thromboprophylaxis in THA (Total Hip Arthroplasty)
A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    enoxaparin ...

  • Study Participants

    80
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 Started
Jan 31
2008
Primary Completion
Jun 30
2008
Study Completion
Apr 30
2009
Last Update
Dec 10
2012
Estimate

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

dalteparin 5000IU s.c. Active Comparator

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

saline Placebo Comparator

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

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.
No Results Posted