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

Study Overview
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Brief Summary
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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.

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

Conditions
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Femoral Neck Fractures, Pertrochanteric Fractures, Antiaggregant Therapy

Intervention / Treatment
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* Procedure: clopidogrel
* Procedure: no antiaggregant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>immediate operation - ORIF - of hip fracture in patient treated with clopidogrel | Procedure: clopidogrel<br>* ORIF - surgical treatment<br>|
| Active Comparator: 2<br>ORIF - surgical treatment patients not on antiaggregant therapy | Procedure: no antiaggregant therapy<br>* ORIF - surgical treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femoral neck fractures, pertrochanteric fractures, antiaggregant therapy, clopidogrel, plavix