Arthritis of the Hip, Infection, Transfusion Related Complications, Wound Discharge
Conditions
Keywords
cemented total hip arthroplasty, blood loss, wound discharge, thromboprophylaxis, biomarkers
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.
Interventions
DRUGdalteparin 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.
Sponsors
Oslo University Hospital
Vestre Viken Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total blood loss | during and after surgery | measured blood loss during surgery and in wound drains |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| transfusion requirements | during and after surgery | number of units packed red blood cells |
| incidence of bleeding events | during and after surgery | excessive bleeding, wound hematoma, wound secretion, other bleeding events |
| other complications | during and after surgery | all other complications related to surgery |
Countries
Norway
Outcome results
None listed