NCT01060176

Brief Summary

Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

9.5 years

First QC Date

January 28, 2010

Last Update Submit

February 1, 2019

Conditions

Hemostasis

Keywords

tranexamic acidcardiac surgery procedureshemostasis

Outcome Measures

Primary Outcomes (1)

  • Rate of exposure to allogeneic erythrocytes transfusions

    Allogeneic RBCs were transfused if the hemoglobin level was less than 6 g/dL during cardiopulmonary bypass, less than 8 g/dL postoperatively, or less than 9 g/dL for elderly people (\>70 years).

    Perioperatively

Secondary Outcomes (9)

  • Volume of allogeneic erythrocytes transfusions

    Perioperatively

  • Rate and volume of fresh frozen plasma transfusion

    Perioperatively

  • Rate and volume of allogeneic platelet transfusion

    Perioperatively

  • Rate of reexploration for hemostasis

    Perioperatively

  • Postoperative blood loss

    Postoperatively

  • +4 more secondary outcomes

Study Arms (4)

High dosage

EXPERIMENTAL

Tranexamic acid with a loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h

Drug: Tranexamic Acid

Medium dosage

EXPERIMENTAL

Tranexamic acid with a loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h

Drug: Tranexamic Acid

Low dosage

EXPERIMENTAL

Tranexamic acid with a loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h

Drug: Tranexamic Acid

Control

PLACEBO COMPARATOR

Saline solution

Drug: Saline Solution

Interventions

Tranexamic AcidDRUG
High dosageLow dosageMedium dosage
Saline SolutionDRUG
Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
  • Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass
  • Wrriten consent obtained

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Interventions

Tranexamic AcidSaline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Lihuan Li, MD

    Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

    STUDY CHAIR

  • Jia Shi, MD

    Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lihuan Li, MD

CONTACT

86-10-88398184llhfw@sina.com

Jia Shi, MD

CONTACT

86-10-88322467shiandypumc@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Vice Chair of the Department of Anesthesiology, Fuwai hospital, NCCD, PUMC & CAMS

Study Record Dates

First Submitted

January 28, 2010

First Posted

February 2, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

CN(1)