search
Back to results

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

Primary Purpose

Femoral Neck Fractures, Pertrochanteric Fractures, Antiaggregant Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
clopidogrel
no antiaggregant therapy
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring femoral neck fractures, pertrochanteric fractures, antiaggregant therapy, clopidogrel, plavix

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

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

    ORIF - surgical treatment patients not on antiaggregant therapy

    Outcomes

    Primary Outcome Measures

    mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications

    Secondary Outcome Measures

    Full Information

    First Posted
    September 8, 2008
    Last Updated
    September 8, 2008
    Sponsor
    Tel-Aviv Sourasky Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00749710
    Brief Title
    Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
    Official Title
    Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femoral Neck Fractures, Pertrochanteric Fractures, Antiaggregant Therapy
    Keywords
    femoral neck fractures, pertrochanteric fractures, antiaggregant therapy, clopidogrel, plavix

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    immediate operation - ORIF - of hip fracture in patient treated with clopidogrel
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    ORIF - surgical treatment patients not on antiaggregant therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    clopidogrel
    Intervention Description
    ORIF - surgical treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    no antiaggregant therapy
    Intervention Description
    ORIF - surgical treatment
    Primary Outcome Measure Information:
    Title
    mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ely Steinberg, MD
    Phone
    972-52-4266346
    Email
    steinberge@tasmc.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    ofir chechik, MD
    Phone
    972-52-2653820
    Email
    ofirchik@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ely Steinberg, MD
    Organizational Affiliation
    Tel-Aviv Sourasky Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16036069
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs