Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel - Full Text View

Sponsor:	Tel-Aviv Sourasky Medical Center
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00749710

Purpose

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.

Condition	Intervention
Femoral Neck Fractures Pertrochanteric Fractures Antiaggregant Therapy	Procedure: clopidogrel Procedure: no antiaggregant therapy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study 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

Resource links provided by NLM:

MedlinePlus related topics: Fractures

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
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)

Arms	Assigned Interventions
Active Comparator: 1 immediate operation - ORIF - of hip fracture in patient treated with clopidogrel	Procedure: clopidogrel ORIF - surgical treatment
Active Comparator: 2 ORIF - surgical treatment patients not on antiaggregant therapy	Procedure: no antiaggregant therapy ORIF - surgical treatment

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749710

Contacts

Contact: Ely Steinberg, MD	972-52-4266346	steinberge@tasmc.health.gov.il
Contact: ofir chechik, MD	972-52-2653820	ofirchik@yahoo.com

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator:

Ely Steinberg, MD

Tel-Aviv Sourasky Medical Center

More Information

Publications:

Wehren LE, Magaziner J. Hip fracture: risk factors and outcomes. Curr Osteoporos Rep. 2003 Sep;1(2):78-85. Review.

Responsible Party:	Steinberg Ely MD, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00749710 History of Changes
Other Study ID Numbers:	TASMC-08-ES-143-CTIL, non
Study First Received:	September 8, 2008
Last Updated:	September 8, 2008
Health Authority:	Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:

femoral neck fractures
pertrochanteric fractures
antiaggregant therapy
clopidogrel
plavix

Additional relevant MeSH terms:

Femoral Neck Fractures
Fractures, Bone
Hemorrhage
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries
Pathologic Processes
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012