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

Infection Clinical Trial

Official title:

A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714297
• Other study ID #: REK Sør-øst s-08012d
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2012
• Last updated: December 7, 2012
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: December 2012
• Source: Martina Hansen's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis of the Hip
• Infection
• Transfusion Related Complications
• Wound Discharge

Intervention

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.

Locations

Country	Name	City	State
Norway	Martina Hansen's Hospital	Sandvika	Gjettum

Sponsors (2)

Lead Sponsor	Collaborator
Martina Hansen's Hospital	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total blood loss	measured blood loss during surgery and in wound drains	during and after surgery	Yes
Secondary	transfusion requirements	number of units packed red blood cells	during and after surgery	Yes
Secondary	incidence of bleeding events	excessive bleeding, wound hematoma, wound secretion, other bleeding events	during and after surgery	Yes
Secondary	other complications	all other complications related to surgery	during and after surgery	Yes