Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
Recruitment status was: Not yet recruiting
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.
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.
|Femoral Neck Fractures Pertrochanteric Fractures Antiaggregant Therapy||Procedure: clopidogrel Procedure: no antiaggregant therapy|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel|
- mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications [ Time Frame: 1 year ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
immediate operation - ORIF - of hip fracture in patient treated with clopidogrel
ORIF - surgical treatment
Active Comparator: 2
ORIF - surgical treatment patients not on antiaggregant therapy
Procedure: no antiaggregant therapy
ORIF - surgical treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749710
|Contact: Ely Steinberg, MDfirstname.lastname@example.org|
|Contact: ofir chechik, MDemail@example.com|
|Principal Investigator:||Ely Steinberg, MD||Tel-Aviv Sourasky Medical Center|