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Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel

NCT ID: NCT00749710

Last Updated: 2008-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Femoral Neck Fractures Pertrochanteric Fractures Antiaggregant Therapy

Keywords

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femoral neck fractures pertrochanteric fractures antiaggregant therapy clopidogrel plavix

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

immediate operation - ORIF - of hip fracture in patient treated with clopidogrel

Group Type ACTIVE_COMPARATOR

clopidogrel

Intervention Type PROCEDURE

ORIF - surgical treatment

2

ORIF - surgical treatment patients not on antiaggregant therapy

Group Type ACTIVE_COMPARATOR

no antiaggregant therapy

Intervention Type PROCEDURE

ORIF - surgical treatment

Interventions

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clopidogrel

ORIF - surgical treatment

Intervention Type PROCEDURE

no antiaggregant therapy

ORIF - surgical treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel-Aviv Sourasky Medical Center

Principal Investigators

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Ely Steinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Central Contacts

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Ely Steinberg, MD

Role: CONTACT

Phone: 972-52-4266346

Email: [email protected]

ofir chechik, MD

Role: CONTACT

Phone: 972-52-2653820

Email: [email protected]

References

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Wehren LE, Magaziner J. Hip fracture: risk factors and outcomes. Curr Osteoporos Rep. 2003 Sep;1(2):78-85. doi: 10.1007/s11914-003-0013-8.

Reference Type BACKGROUND
PMID: 16036069 (View on PubMed)

Other Identifiers

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non

Identifier Type: -

Identifier Source: secondary_id

TASMC-08-ES-143-CTIL

Identifier Type: -

Identifier Source: org_study_id