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

Martina Hansen's Hospital

Status and phase: Completed; Phase 4

Conditions: Infection; Arthritis of the Hip; Transfusion Related Complications; Wound Discharge

Treatments: Drug: dalteparin 5000 IU s.c.

Study type: Interventional

Funder types: Other

Identifiers

NCT01714297

REK Sør-øst s-08012d

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups, including a placebo group

dalteparin 5000IU s.c.

Active Comparator group

Description:

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

Treatment:

Drug: dalteparin 5000 IU s.c.

saline

Placebo Comparator group

Description:

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

Treatment:

Drug: dalteparin 5000 IU s.c.