Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion

Not Applicable

Completed

• Conditions: Degenerative Arthritis of Hip; Avascular Necrosis of Femoral Head
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT02146456
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-23
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid	During the operation, Lactate Ringer's solution is used as the maintenance fluid, and colloid is infused for the compensation of the intraoperative blood loss. In addition, 1 g of tranexamic acid in 100 ml normal saline is administered intravenously over 30 min after finishing the procedure of hip implant insertion.

Primary Outcome Measures

Name	Time	Method
Rotational thromboelastography	30 minutes before starting an operation and 30 minutes after finishing an operation

Secondary Outcome Measures

Name	Time	Method
International normalized ratio of prothrombin time	30 minutes before starting an operation and 30 minutes after finishing an operation
Platelet	30 minutes before starting an operation and 30 minutes after finishing an operation
Hemoglobin	30 minutes before starting an operation and 30 minutes after finishing an operation
Activated partial thromboplastin time	30 minutes before starting an operation and 30 minutes after finishing an operation
Fibrinogen	30 minutes before starting an operation and 30 minutes after finishing an operation

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of