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

NCT ID: NCT04165538

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2022-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TEG group

Group Type: EXPERIMENTAL

Thrombelastograph and surgical timing

Intervention Type: 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.

Non-TEG group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Thrombelastograph and surgical timing

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.

Intervention Type: PROCEDURE

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.)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Yan, Doctor

Role: STUDY_DIRECTOR

Zhejiang University

Central Contacts

Min Yan, Doctor

Role: CONTACT

zryanmin@zju.edu.cn

+86-13757118632

Other Identifiers

2019-324

Identifier Type: -

Identifier Source: org_study_id