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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
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Femoral Neck Fractures Pertrochanteric Fractures Antiaggregant Therapy Procedure: clopidogrel Procedure: no antiaggregant therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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:
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
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: September 9, 2008
Last Verified: September 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
femoral neck fractures
pertrochanteric fractures
antiaggregant therapy
clopidogrel
plavix

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
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
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors