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Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion

The Effect of Tranexamic Acid on Blood Coagulation After Colloid Infusion During Surgery: Rotational Thromboelastography Measurement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02146456
Enrollment
60
Registered
2014-05-23
Start date
2014-05-31
Completion date
2015-05-31
Last updated
2015-06-17

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

Conditions

Avascular Necrosis of Femoral Head, Degenerative Arthritis of Hip

Brief summary

Colloid solution is generally used to maintain intravascular volume. It is reported to impair blood coagulation in vivo and in vitro more than crystalloid does by prolonging coagulation time and decreasing clot strength. The formed fibrin clot is more vulnerable for fibrinolysis in a case of using colloid. Dilution of plasmin in vitro with colloid enhances fibrinolysis primarily by diminishing α2-antiplasmin-plasmin interaction. Tranexamic acid is an antifibrinolytics that competitively inhibits the activation of plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clot. It is used to treat or prevent excessive blood loss during surgery and in other medical conditions. Gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity reaction, or potential risk of thrombosis is reported as the adverse effect of tranexamic acid. We hypothesized that inhibition of plasmin by tranexamic acid after colloid administration can improve the colloid-induced clot strength impairment.

Interventions

DRUGTranexamic Acid

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing total hip replacement arthroplasty, who are diagnosed with the avascular necrosis of femoral head or degenerative arthritis of hip * American Society of Anesthesiologist I or II

Exclusion criteria

* Patients receiving an intraoperative transfusion * Patients receiving thrombin * Patients having venous thromboembolism * Patients having renal or hepatic disease * Patients having coagulopathy * Patient having heart failure

Design outcomes

Primary

MeasureTime frame
Rotational thromboelastography30 minutes before starting an operation and 30 minutes after finishing an operation

Secondary

MeasureTime frame
Hemoglobin30 minutes before starting an operation and 30 minutes after finishing an operation
Platelet30 minutes before starting an operation and 30 minutes after finishing an operation
International normalized ratio of prothrombin time30 minutes before starting an operation and 30 minutes after finishing an operation
Activated partial thromboplastin time30 minutes before starting an operation and 30 minutes after finishing an operation
Fibrinogen30 minutes before starting an operation and 30 minutes after finishing an operation

Countries

South Korea

Outcome results

None listed

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