Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
Information source: Tel-Aviv Sourasky Medical Center
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Femoral Neck Fractures; Pertrochanteric Fractures; Antiaggregant Therapy
Intervention: clopidogrel (Procedure); no antiaggregant therapy (Procedure)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Tel-Aviv Sourasky Medical Center Official(s) and/or principal investigator(s):
Ely Steinberg, MD, Principal Investigator, Affiliation: Tel-Aviv Sourasky Medical Center
Overall contact:
Ely Steinberg, MD, Phone: 972-52-4266346, Email: steinberge@tasmc.health.gov.il
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.
Clinical Details
Official title: Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: mortality 30 days, 1 year
functional score 1 year
blood loss at surgery
blood transfusions during hospitalization
wound complications
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Ely Steinberg, MD, Phone: 972-52-4266346, Email: steinberge@tasmc.health.gov.il Additional Information
Related publications: Wehren LE, Magaziner J. Hip fracture: risk factors and outcomes. Curr Osteoporos Rep. 2003 Sep;1(2):78-85. Review.
Starting date: September 2008
Ending date: December 2012
Last updated: September 8, 2008
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