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Completed

NCT Number: NCT01060189

Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive, and has been proved to link to higher risks of serious side effects including renal problems, myocardial events, and strokes in patients undergoing CABG. After the secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin, urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic acid in cardiac surgery.

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Key information

Conditions

Hemostasis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Atrial or ventricular septum defect patients requiring cardiac surgery with CPB
  • Rheumatic or recessive valvular patients requiring valvular repair or replacement with CPB
  • Coronary artery disease patients requiring coronary revascularization surgery with CPB

Exclusion criteria

  • Non-primary cardiac surgery
  • Definite liver or renal dysfunction
  • Disorder in coagulation function
  • Allergy
  • Pregnancy or lactation
  • Disabled in spirit or law
  • Fatal conditions such as tumour

Treatment and study plan

Ulinastatin

Drug

Tranexamic Acid

Drug

Saline Solution

Drug

Primary outcomes

  1. Postoperative blood loss

    Time frame: Postoperatively

    Defined as the total volume of chest drainage postoperatively

Secondary outcomes

  1. Rate of reexploration for bleeding

    Time frame: Postoperatively

  2. Rate of major bleeding

    Time frame: Perioperatively

    Major bleeding is defined according to the CURE study

  3. Transfusion of allogeneic erythrocytes

    Time frame: Perioperatively

    Rate of exposure and volume of allogeneic erythrocytes transfused

  4. Transfusion of fresh frozen plasma (FFP)

    Time frame: Perioperatively

    Rate of exposure and volume of FFP transfused

  5. Transfusion of allogeneic platelets

    Time frame: Perioperatively

    Rate of exposure and volume of allogeneic platelets transfused

  6. Length of stay in ICU and hospital postoperatively

    Time frame: Postoperatively

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2019
First posted
Feb 2, 2010
Registry last updated
Feb 5, 2019

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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