Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel

Not Applicable

• Conditions: Femoral Neck Fractures; Pertrochanteric Fractures; Antiaggregant Therapy
• Interventions: Procedure: clopidogrel; Procedure: no antiaggregant therapy

• Registration Number: NCT00749710
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

Patients suffering from femoral neck or pertrochanteric fractures have a high rate of mortality and morbidity associated mainly with deconditioning and immobilization. Surgical management including open reduction and internaql fixation has been shown to reduce complication and improve outcome in such patients. Delay of surgery produces less optimal results and is associated with higher morbidity even after 24-48 hours of fracture event.

Patients treated with platelet antiaggregants are exposed to higher blood loss during surgery and related complications, as demonstrated in patients treated with Aspirin. However, cessation of antiaggregant therapy before surgery may be associated with complications of a hypercoagulable state and surgery delay.

Clpopidogrel is a fairly new approved antiaggregant drug indicated in cases of failed aspirin treatment in ischemic heart disease and cerebrovascular disease patients as well as in primary prevention of stent restenosis.

No data regarding complications of hip surgery in patients treated with Clpopidogrel is available.

Study hypothesis:

Definitive surgical treatment of patients treated with clopidogrel undergoing open reduction and internal fixation of pertrochnteric and femoral neck fractures is safe although associated with more extensive blood loss during surgery and postoperative wound complications.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-09
• Study Start: 2008-09
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Last Update Submitted: 2008-09-08
• Study First Posted: 2008-09-09
• Last Update Posted: 2008-09-09
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age > 60
• pertrochanteric or femoral neck fracture within 48 hours
• clopidogrel treatment - study group
• no antiaggregant treatment - control group
• ASA score <=3

Exclusion Criteria

• hematologic malignancy
• hematologic malfunction
• warfarin treatment
• previous active GI or other internal bleeding - within 1 year
• thrombocytopenia < 150

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	clopidogrel	immediate operation - ORIF - of hip fracture in patient treated with clopidogrel
2	no antiaggregant therapy	ORIF - surgical treatment patients not on antiaggregant therapy

Primary Outcome Measures

Name	Time	Method
mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications	1 year