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
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 23, 2012
CompletedFirst Posted
Study publicly available on registry
October 25, 2012
CompletedDecember 10, 2012
December 1, 2012
5 months
October 23, 2012
December 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total blood loss
measured blood loss during surgery and in wound drains
during and after surgery
Secondary Outcomes (3)
transfusion requirements
during and after surgery
incidence of bleeding events
during and after surgery
other complications
during and after surgery
Study Arms (2)
dalteparin 5000IU s.c.
ACTIVE COMPARATOR5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty
saline
PLACEBO COMPARATORSyringes 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients 50 years or older undergoing cemented total hip arthroplasty for primary osteoarthritis
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vestre Viken Hospital Trustlead
- Oslo University Hospitalcollaborator
Study Sites (1)
Martina Hansen's Hospital
Sandvika, Gjettum, 1346, Norway
Related Publications (1)
Borgen PO, Dahl OE, Reikeras 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.
PMID: 22476844RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Olav Reikeras, MD, Phd
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD.
Study Record Dates
First Submitted
October 23, 2012
First Posted
October 25, 2012
Study Start
January 1, 2008
Primary Completion
June 1, 2008
Study Completion
April 1, 2009
Last Updated
December 10, 2012
Record last verified: 2012-12