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Completed

NCT Number: NCT02146456

Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

Primary outcomes

  1. Rotational thromboelastography

    Time frame: 30 minutes before starting an operation and 30 minutes after finishing an operation

Secondary outcomes

  1. Hemoglobin

    Time frame: 30 minutes before starting an operation and 30 minutes after finishing an operation

  2. Platelet

    Time frame: 30 minutes before starting an operation and 30 minutes after finishing an operation

  3. International normalized ratio of prothrombin time

    Time frame: 30 minutes before starting an operation and 30 minutes after finishing an operation

  4. Activated partial thromboplastin time

    Time frame: 30 minutes before starting an operation and 30 minutes after finishing an operation

  5. Fibrinogen

    Time frame: 30 minutes before starting an operation and 30 minutes after finishing an operation

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 23, 2014
Registry last updated
Jun 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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