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

Hip Fracture Clinical Trial

Official title:

Safety and Effectiveness of Clopidogrel Withdrawal Time Guided by Thromboelastography in Elderly Patients With Hip Fracture

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04165538
• Other study ID #: 2019-324
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: January 2022

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Yan, Doctor
• Phone: +86-13757118632
• Email: zryanmin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay	Total length of stay	from admission to discharge,up to one year after operation
Other	Mortality	One year all-cause mortality	within one year after operation
Other	Cerebrovascular accident	Ischemic brain disease	within one year after operation
Other	Acute coronary syndrome	Ischemic heart disease	within one year after operation
Primary	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	Blood transfusion	Red blood cell infusion volume	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.