Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion

Seoul National University

Status: Completed

Conditions: Avascular Necrosis of Femoral Head; Degenerative Arthritis of Hip

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02146456

Colloid_tranexamic acid

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Colloid

No Intervention group

Description:

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.

Tranexamic acid

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid