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Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

NCT01060189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2019-02-05

No results posted yet for this study

Summary

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.

Conditions

  • Hemostasis

Interventions

DRUG

Ulinastatin

DRUG

Tranexamic Acid

DRUG

Saline Solution

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

  • Lihuan Li, MD · Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

  • Jia Shi, MD · Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-01-31
Completion
2019-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060189 on ClinicalTrials.gov