Clinical trial NCT04165538: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fracture
Keywords: Hip Fracture
Clopidogrel
Withdrawal
surgical timing
Thromboelastogram
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.)

Primary outcomes:
measure: Estimated red blood cell loss
timeFrame: 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:
measure: Blood transfusion
timeFrame: 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:
measure: Length of stay
timeFrame: from admission to discharge,up to one year after operation
measure: Mortality
timeFrame: within one year after operation
measure: Cerebrovascular accident
timeFrame: within one year after operation
measure: Acute coronary syndrome
timeFrame: within one year after operation
Locations:
Study officials:
affiliation: Zhejiang University
name: Min Yan, Doctor
role: STUDY_DIRECTOR
References: