The effect of tranexamic acid on reducing of bleeding during spinal fixation surgery

Comparison of two doses of tranexamic acid on reducing of bleeding during spinal fusion surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015101924601N1

Enrollment

102

Registered

2015-11-29

Start date

2015-11-06

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

The effect of two different form Tranexamic Acid administration for bleeding reduction at spinal fixation surgery. Haemorrhagic condition, unspecified

Interventions

Intervention 1: Infusion 10 mg/kg of tranexamic acid by microset with total volume of 100 cc during 10 minutes before skin incision and continued with 20 drop/ min of normal saline as placebo. Interv

Treatment - Drugs

Placebo

Infusion 10 mg/kg of tranexamic acid by microset with total volume of 100 cc during 10 minutes before skin incision and continued with 20 drop/ min of normal saline as placebo

Infusion 10 mg/kg of tranexamic acid by microset with total volume of 100 cc during 10 minutes before skin incision and continued by 1 mg/kg/hour drug infusion untill end of surgery

control group: infusion of 100 cc normal saline during 10 minutes and continued infusion with 20 drop/min untill end of suegery as placebo

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: the patients aged beetween 18 and 60 years old with class ASA 1 and 2 (american anesthesia society) that admitted for spinal fixation surgery. Exclusion criteria: the patient's Dissatisfaction.the patients with thrombotic diseases. the use of antithrombotic drugs. history of cardiovascular and cerebral disease. hypertention. deep vein thrombosis. pulmonary emboli. peripheral vascular disease. pregnant and lactating women and history of allergy to tranexamic acid

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The volume of bleeding due to surgery. Timepoint: The end of surgery and 24 hours later. Method of measurement: The volume of blood in suction after reducing washing serum and scale of bloody guases by digital scale.;The volume of blood transfused to patient. Timepoint: at the surgery time untill 24 hours later. Method of measurement: the amount of pack cell transfused.	—

Secondary

Measure	Time frame
Hemodynamic variation. Timepoint: Before anesthesia and then every 30 minuets. Method of measurement: Noninvasive digital blood pressure monitor and pulseoximetry.;Complication due to drug(nausea. vomitting. abdominal pain. skin reactions. DVT. pulmonary emboli. CAD. CVA). Timepoint: The end of surgery in recovery and 24 hours later in hospitalization wards. Method of measurement: Visit and interview with patients.;Surgery duration. Timepoint: From incison of skin till end of skin suture. Method of measurement: To minute.	—

Measure

Time frame

Hemodynamic variation. Timepoint: Before anesthesia and then every 30 minuets. Method of measurement: Noninvasive digital blood pressure monitor and pulseoximetry.;Complication due to drug(nausea. vomitting. abdominal pain. skin reactions. DVT. pulmonary emboli. CAD. CVA). Timepoint: The end of surgery in recovery and 24 hours later in hospitalization wards. Method of measurement: Visit and interview with patients.;Surgery duration. Timepoint: From incison of skin till end of skin suture. Method of measurement: To minute.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Mohammadian Erdi

Ardabil University of Medical Sciences

A.mohammadian@arums.ac.ir+98 45 3323 2520

Outcome results

None listed

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