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STUDY OF TRANAXAMIC ACID DOSAGE IN PEDIATRIC CARDIAC SURGERY - DOSAGE TRANEXAMIC ACID IN PAEDIATRIC

STUDY OF TRANAXAMIC ACID DOSAGE IN PEDIATRIC CARDIAC SURGERY - DOSAGE TRANEXAMIC ACID IN PAEDIATRIC

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-018301-11-FR
Enrollment
18
Registered
2010-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

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

Conditions

DOSAGE OF ACID TRANEXAMIC ACID IN BLOOD SAMPLES DURING PAEDIATRIC CARDIAC SURGERY

Interventions

Trade Name: EXACYL Product Name: exacyl Pharmaceutical Form: Concentrate and solvent for solution for injection

Sponsors

Centre chirurgical Marie Lannelongue
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: CARDIAC SURGERY CHILDREN WHEITING MORE THAN 10 KG AND LESS THAN 30 KG HEMMORRAGIC INTERVENTIONS Patients operated on by sternotomy Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: CHIDREN UNDER ONE YEAR OLD ALLERICREACTION TO THE PRODUCT Renal insuffisancy: The value of the creatinine clearance will be the one obtained by the Schwartz formula (Pediatrics. 1976, 58, 259-263). Any alteration of this clearance will be an indication cons

Design outcomes

Primary

MeasureTime frame
Main Objective: OBTAIN GUIDELINES FOR ADMINISTRATION OF THE PRODUCT IN CARDIAC SURGERY;Secondary Objective: STUDY IF FIBRINOLYSIS STILL EXISTS OR NOT NEUROLOGIC TOXICITY;Primary end point(s): NO PRIMARY END POINT—

Countries

France

Outcome results

None listed

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