Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
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|ClinicalTrials.gov Identifier: NCT00749710|
Recruitment Status : Unknown
Verified September 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : September 9, 2008
Last Update Posted : September 9, 2008
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.
|Condition or disease||Intervention/treatment|
|Femoral Neck Fractures Pertrochanteric Fractures Antiaggregant Therapy||Procedure: clopidogrel Procedure: no antiaggregant therapy|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
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
- mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749710
|Contact: Ely Steinberg, MDfirstname.lastname@example.org|
|Contact: ofir chechik, MDemail@example.com|
|Principal Investigator:||Ely Steinberg, MD||Tel-Aviv Sourasky Medical Center|