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Clinical Trials/NCT00749710
NCT00749710
Unknown
Not Applicable

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

Tel-Aviv Sourasky Medical Center0 sites100 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femoral Neck Fractures
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
100
Primary Endpoint
mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
December 2012
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 1 year

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