Tranexamic acid, controlled hypotension or their combination for reduction in bleeding due to craniocynostosis

Comparison of tranexamic acid administration and controlled hypotension or combination of them for bleeding reduction during craniocynostosis surgery in Imam Hossein Hospital in Isfahan in 2016-17

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190328043128N1

Enrollment

Registered

2020-03-04

Start date

2017-03-21

Completion date

Unknown

Last updated

2020-03-24

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

Conditions

Bleeding during craniosynostosis. Craniosynostosis

Interventions

Intervention 1: The first Intervention group: Tranexamic acid

10 mg/kg

Immediately after anesthesia induction. Intervention 2: The second Intervention group: Controlled hypotension

The manipulation of mean arterial pressure at 30 mmHg less than mean arterial pressure before the anesthesia induction or regulation of mean arterial pressure at 50-60 mmHg

Immediately after anesthesia induction. Intervention 3: The third Intervention group: Combination of Tranexamic acid with controlled hypotension

10 mg/kg of tranexamic acid plus the manipulation of mean arterial pressure at 30 mmHg less than mean arterial pressure before the anesthesia induction or regulation of mean arterial pressure at 50-60

Immediately after anesthesia induction.

Eligibility

Sex/Gender

All

Age

3 Months to 12 Months

Inclusion criteria

Inclusion criteria: Physical status of I-II based on American Society of Anesthesiology Age of 3 months to 12 months

Exclusion criteria

Exclusion criteria: Cardiac disease Liver disease Renal disease Pulmonary disease Congenital anomaly

Design outcomes

Primary

Measure	Time frame
Amount of bleeding. Timepoint: During the surgery. Method of measurement: Gradient container contained suctioned blood.;The amount of transfused blood. Timepoint: During the surgery and admission at intensive care unit. Method of measurement: Pack cell.;The amount of transfused fresh frozen plasma. Timepoint: During the surgery and admission at intensive care unit. Method of measurement: Pack cell.	—

Measure

Time frame

Amount of bleeding. Timepoint: During the surgery. Method of measurement: Gradient container contained suctioned blood.;The amount of transfused blood. Timepoint: During the surgery and admission at intensive care unit. Method of measurement: Pack cell.;The amount of transfused fresh frozen plasma. Timepoint: During the surgery and admission at intensive care unit. Method of measurement: Pack cell.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Shafa

Esfahan University of Medical Sciences

shafa_amir@yahoo.com+98 31 3668 0048

Outcome results

None listed

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