NCT00588133

Brief Summary

Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have developed an alternative dosing schedule for tranexamic acid. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 10, 2009

Status Verified

November 1, 2009

Enrollment Period

3.9 years

First QC Date

December 25, 2007

Last Update Submit

November 9, 2009

Conditions

Cardiac Surgery

Keywords

antifibrinolytic, bleeding, heart

Outcome Measures

Primary Outcomes (1)

  • Plasma tranexamic acid levels

    24 hours

Study Arms (2)

1

EXPERIMENTAL

New drug dosing schedule

Drug: tranexamic acid

2

ACTIVE COMPARATOR

Standard drug dosing schedule

Drug: tranexamic acid

Interventions

tranexamic acidDRUG

Loading dose: 6.6 mg/kg Prime dose: 50 mg for 2.5 Liter circuit (assuming 1 L/kg Vd in prime fluids), 40 mg for 2 Liter circuit Rate of infusion: 6 mg/kg/hr Renal Insufficiency (normal loading dose and prime dose): Serum Creatinine = 1.6-3.3: reduce infusion to 4.5 mg/kg/hr Serum Creatinine = 3.3-6.6: reduce infusion to 3.0 mg/kg/hr Serum Creatinine = \>6.6: reduce infusion to 1.5 mg/kg/hr

Also known as: Cyclokapron
1

Eligibility Criteria

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

You may qualify if:

  • Age 18 years old or greater having cardiac surgery.

You may not qualify if:

  • Age less than 18 years old.
  • Since tranexamic acid is not approved for pregnant patients, those extremely rare patients that are pregnant and having cardiac surgery will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Gregory A. Nuttall, M.D.

    Mayo Clinic College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 25, 2007

First Posted

January 8, 2008

Study Start

January 1, 2004

Primary Completion

December 1, 2007

Study Completion

August 1, 2008

Last Updated

November 10, 2009

Record last verified: 2009-11