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Thromboelastography (TEG) and Clopidogrel Withdrawal Time in Elderly Patients With Hip Fracture

Primary Purpose

Hip Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thrombelastograph and surgical timing
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Hip Fracture, Clopidogrel, Withdrawal, surgical timing, Thromboelastogram

Eligibility Criteria

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

Inclusion Criteria:

  • hip fracture and operation
  • taking clopidogrel for more than one week before injury, with or without taking aspirin at the same time

Exclusion Criteria:

  • high energy injury (such as traffic accident, falling from height), bilateral hip fracture, multiple fractures or injuries, pathological fracture
  • malignant tumor patients
  • hormone users
  • patients with recent active bleeding or bleeding ulcer
  • primary or secondary coagulation dysfunction or depression caused by other reasons than taking antiplatelet drugs (for example, taking warfarin)
  • patients with other acute or unstable diseases requiring delayed surgery (acute heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, severe pulmonary infection, deep vein thrombosis or pulmonary embolism, etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    TEG group

    Non-TEG group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Estimated red blood cell loss
    The amount of red blood cell loss estimated by blood routine changes

    Secondary Outcome Measures

    Blood transfusion
    Red blood cell infusion volume

    Full Information

    First Posted
    October 16, 2019
    Last Updated
    November 14, 2019
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04165538
    Brief Title
    Thromboelastography (TEG) and Clopidogrel Withdrawal Time in Elderly Patients With Hip Fracture
    Official Title
    Safety and Effectiveness of Clopidogrel Withdrawal Time Guided by Thromboelastography in Elderly Patients With Hip Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    January 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In the elderly patients with hip fracture, some often take antiplatelet drugs such as clopidogrel due to the ischemic cardiovascular or cerebrovascular diseases. In traditional practice, these patients often need to stop medication for 5-7 days before surgery. But on the other hand, delayed surgery will lead to a significant increase in fracture related complications. Therefore, the appropriate time for drug withdrawal is particularly important in this population. Thromboelastography is a monitoring method that can accurately judge the anticoagulation status of patients. We hope to use thromboelastography to guide the time of drug withdrawal, shorten the time of drug withdrawal as much as possible, and reduce the incidence of fracture related complications without increasing the risk of massive hemorrhage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Fracture
    Keywords
    Hip Fracture, Clopidogrel, Withdrawal, surgical timing, Thromboelastogram

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TEG group
    Arm Type
    Experimental
    Arm Title
    Non-TEG group
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    Thrombelastograph and surgical timing
    Intervention Description
    Patients in the TEG group will undergo a Thrombelastograph test after admission, and the timing of operation will be determined according to the results of the test, that is, 1 day, 3 days and 5 days later respectively for patients with ADP-induced platelet-fibrin clot strength (MAADP) of > 50 mm, 30-50 mm and < 30 mm. For Non-TEG patients, the drug withdrawal time is determined by the doctor in charge according to the clinical routine, generally about one week.
    Primary Outcome Measure Information:
    Title
    Estimated red blood cell loss
    Description
    The amount of red blood cell loss estimated by blood routine changes
    Time Frame
    From admission when the first blood routine will be obtained to discharge when the last blood routine will be obtained, up to postoperative day 7.
    Secondary Outcome Measure Information:
    Title
    Blood transfusion
    Description
    Red blood cell infusion volume
    Time Frame
    From admission when the first blood routine will be obtained to discharge when the last blood routine will be obtained, up to postoperative day 7.
    Other Pre-specified Outcome Measures:
    Title
    Length of stay
    Description
    Total length of stay
    Time Frame
    from admission to discharge,up to one year after operation
    Title
    Mortality
    Description
    One year all-cause mortality
    Time Frame
    within one year after operation
    Title
    Cerebrovascular accident
    Description
    Ischemic brain disease
    Time Frame
    within one year after operation
    Title
    Acute coronary syndrome
    Description
    Ischemic heart disease
    Time Frame
    within one year after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: hip fracture and operation taking clopidogrel for more than one week before injury, with or without taking aspirin at the same time Exclusion Criteria: high energy injury (such as traffic accident, falling from height), bilateral hip fracture, multiple fractures or injuries, pathological fracture malignant tumor patients hormone users patients with recent active bleeding or bleeding ulcer primary or secondary coagulation dysfunction or depression caused by other reasons than taking antiplatelet drugs (for example, taking warfarin) patients with other acute or unstable diseases requiring delayed surgery (acute heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, severe pulmonary infection, deep vein thrombosis or pulmonary embolism, etc.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Min Yan, Doctor
    Phone
    +86-13757118632
    Email
    zryanmin@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Min Yan, Doctor
    Organizational Affiliation
    Zhejiang University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Thromboelastography (TEG) and Clopidogrel Withdrawal Time in Elderly Patients With Hip Fracture

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