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

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.

Study Overview

• Status: Completed
• Conditions: Avascular Necrosis of Femoral Head; Degenerative Arthritis of Hip
• Intervention / Treatment: Drug: Tranexamic Acid

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Colloid; 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.
Experimental: 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.	Drug: Tranexamic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rotational thromboelastography	30 minutes before starting an operation and 30 minutes after finishing an operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin	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
International normalized ratio of prothrombin time	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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Estimate): June 17, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Necrosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: Colloid_tranexamic acid