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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hip Fracture
• Intervention / Treatment: Procedure: Thrombelastograph and surgical timing

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEG group	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.
No Intervention: Non-TEG group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Total length of stay	from admission to discharge,up to one year after operation
Mortality	One year all-cause mortality	within one year after operation
Cerebrovascular accident	Ischemic brain disease	within one year after operation
Acute coronary syndrome	Ischemic heart disease	within one year after operation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Hip Fracture; Clopidogrel; Withdrawal; surgical timing; Thromboelastogram
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 2019-324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No