NCT01998438

Brief Summary

Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
955

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 26, 2016

Completed
Last Updated

February 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

November 12, 2013

Results QC Date

January 29, 2016

Last Update Submit

January 29, 2016

Conditions

C.Surgical Procedure; Cardiac

Keywords

tranexamic acidcardiac surgerycardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • Postoperative Blood Loss

    24hrs postoperatively

Secondary Outcomes (1)

  • Number of Participants Needs Allogenic Transfusion

    on the 7th day postoperatively

Other Outcomes (1)

  • Rate of Reexploration for Bleeding

    on the 7th day postoperatively

Study Arms (3)

small dose

EXPERIMENTAL

10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery

Drug: Tranexamic Acid

medium dose

EXPERIMENTAL

20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery

Drug: Tranexamic Acid

large dose

EXPERIMENTAL

30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery

Drug: Tranexamic Acid

Interventions

Tranexamic AcidDRUG

The loading doses were given in 15 minutes when incision.

Also known as: SINE, Tranexamic Acid Injection, 120902
large dosemedium dosesmall dose

Eligibility Criteria

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

You may qualify if:

  • Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass
  • Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass
  • Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass

You may not qualify if:

  • Non-primary and emergency cardiac surgery
  • Disorder in coagulation function before surgery
  • Anemia before surgery
  • Definite liver and renal dysfunction
  • History of stroke
  • Pregnancy and lactation
  • Disabled in spirit or law
  • Fatal conditions such as cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Interventions

Tranexamic AcidShort Interspersed Nucleotide Elements

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsRetroelementsInterspersed Repetitive SequencesRepetitive Sequences, Nucleic AcidBase SequenceMolecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic PhenomenaGenome ComponentsGenome

Results Point of Contact

Title
Dr. Hongwen Ji
Organization
Fuwai Hospital
jihongwen@hotmail.com
+86 13701229553

Study Officials

  • Hongwen Ji, MD

    Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

    STUDY CHAIR

  • Haisong Lu

    Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor of medicine

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 28, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 26, 2016

Results First Posted

February 26, 2016

Record last verified: 2016-01

Locations

CN(1)