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

NCT04165538 | Unknown

• 1 other identifier: 2019-324
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Fracture

Keywords

Hip Fracture; Clopidogrel; Withdrawal; surgical timing; Thromboelastogram

Outcome Measures

Primary Outcomes (1)

• Estimated red blood cell loss

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

  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 Outcomes (1)

• Blood transfusion

  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 Outcomes (4)

• Length of stay

  from admission to discharge,up to one year after operation

• Mortality

  within one year after operation

• Cerebrovascular accident

  within one year after operation

Study Arms (2)

TEG group

EXPERIMENTAL

Procedure: Thrombelastograph and surgical timing

Non-TEG group

NO INTERVENTION

Interventions

Thrombelastograph and surgical timing PROCEDURE

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.

TEG group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Min Yan, Doctor

  Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Min Yan, Doctor

CONTACT

+86-13757118632; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: November 18, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: November 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR