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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04165538
Enrollment
140
Registered
2019-11-18
Start date
2020-01-31
Completion date
2022-01-31
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture

Keywords

Hip Fracture, Clopidogrel, Withdrawal, surgical timing, Thromboelastogram

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.

Interventions

PROCEDUREThrombelastograph 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Estimated red blood cell lossFrom admission when the first blood routine will be obtained to discharge when the last blood routine will be obtained, up to postoperative day 7.The amount of red blood cell loss estimated by blood routine changes

Secondary

MeasureTime frameDescription
Blood transfusionFrom admission when the first blood routine will be obtained to discharge when the last blood routine will be obtained, up to postoperative day 7.Red blood cell infusion volume

Other

MeasureTime frameDescription
Length of stayfrom admission to discharge,up to one year after operationTotal length of stay
Mortalitywithin one year after operationOne year all-cause mortality
Cerebrovascular accidentwithin one year after operationIschemic brain disease
Acute coronary syndromewithin one year after operationIschemic heart disease

Contacts

Primary ContactMin Yan, Doctor
zryanmin@zju.edu.cn+86-13757118632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026