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

This study has been completed.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Pål Borgen, MD, Martina Hansen's Hospital
ClinicalTrials.gov Identifier:
NCT01714297
First received: October 23, 2012
Last updated: December 7, 2012
Last verified: December 2012
History of Changes

October 23, 2012
December 7, 2012
January 2008
June 2008   (final data collection date for primary outcome measure)
total blood loss [ Time Frame: during and after surgery ] [ Designated as safety issue: Yes ]
measured blood loss during surgery and in wound drains
blood loss [ Time Frame: during 6 postoperative months ] [ Designated as safety issue: Yes ]
measured blood loss
Complete list of historical versions of study NCT01714297 on ClinicalTrials.gov Archive Site
  • transfusion requirements [ Time Frame: during and after surgery ] [ Designated as safety issue: Yes ]
    number of units packed red blood cells
  • incidence of bleeding events [ Time Frame: during and after surgery ] [ Designated as safety issue: Yes ]
    excessive bleeding, wound hematoma, wound secretion, other bleeding events
  • other complications [ Time Frame: during and after surgery ] [ Designated as safety issue: Yes ]
    all other complications related to surgery
Not Provided
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Arthritis of the Hip
  • Transfusion Related Complications
  • Infection
  • Wound Discharge
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 Name: Fragmin
  • Active Comparator: dalteparin 5000IU s.c.
    5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty
    Intervention: Drug: dalteparin 5000 IU s.c.
  • 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
    Intervention: Drug: dalteparin 5000 IU s.c.
Borgen PO, Dahl OE, Reikerås O. Blood loss in cemented THA is not reduced with postoperative versus preoperative start of thromboprophylaxis. Clin Orthop Relat Res. 2012 Sep;470(9):2591-8. doi: 10.1007/s11999-012-2320-9. Epub 2012 Apr 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2009
June 2008   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01714297
REK Sør-øst s-08012d
No
Pål Borgen, MD, Martina Hansen's Hospital
Martina Hansen's Hospital
Oslo University Hospital
Study Chair: Olav Reikeras, MD, Phd Oslo University Hospital
Martina Hansen's Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP