Validation of a new dosing regimen for tranexamic acid in children under 1 year of age undergoing cardiac surgery

Validation of a new dosing regimen for tranexamic acid in children under 1 year of age undergoing cardiac surgery - Votac

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00012781

Enrollment

Registered

2017-11-02

Start date

2017-10-30

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q20-Q28

Interventions

Group 1: Blood samples are taken for measurement of tranexamic acid plasma concentrations Timepoints: 5min after injection, 60min after injection, prior initiation of extracorporeal Circulation (ECC)

Eligibility

Sex/Gender

All

Age

1 Days to 1 Years

Inclusion criteria

Inclusion criteria: cardiac surgery requirin ECC, Age < 366 days

Exclusion criteria

Exclusion criteria: -missing informed consent -known disturbance of hemostasis - preoperative treatment with medications affecting hemostasis - hypersensitivity on tranexamic acid - known renal insufficiency - age _>366 days

Design outcomes

Primary

Measure	Time frame
Primary outcome is the testing of the overlap of the measured tranexamic acid concentration with the 90% confidence interval of the pharmacokinetc model.	—

Secondary

Measure	Time frame
Testing whether the tranexamic acid concentration is within the therapeutic range (20 - 125 µg/ml) throughout the entire surgical procedure.	—

Countries

Germany

Contacts

Public ContactKlaus Martin

Institut für AnästhesiologieDeutsches Herzzentrum München

martin@dhm.mhn.de08912184611

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026