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Comparison of intravenous tranexamic acid and intravenous fibrinogen on bleeding control in posterior lumbar spine fusion surgery.

Comparison of intravenous tranexamic acid and intravenous fibrinogen on bleeding control in posterior lumbar spine fusion surgery.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210415050983N4
Enrollment
40
Registered
2023-03-06
Start date
2023-04-21
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

Lumbar Discopathy. Intervertebral disc disorders with myelopathy, thoracolumbar region

Interventions

Intervention 1: The group receiving tranexamic acid: 15-30 minutes before surgical incision, 15mg/kg tranexamic acid, which has been diluted with normal saline to a volume of 20 cc, will be administer
CSL Behring, Pennsylvania) dissolved in 50 ml of distilled water was administered intravenously as described by the manufacturer they receive . Intervention 3: Control group: They receive an equal vol

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: No history of drug allergy No history of thromboembolism and coagulation disorders No history of liver or kidney failure No history of heart disease and hypertension ASA I , II Patient consent to participate in the study

Exclusion criteria

Exclusion criteria: use of anticoagulants History of blood disorders and coagulopathy History of liver disease History of chronic kidney disease and creatinine greater than 2mg / dl History of thromboembolic events at any time

Design outcomes

Primary

MeasureTime frame
Determination of intraoperative bleeding in groups receiving tranexamic acid ,fibrinogen and control group. Timepoint: End of surgery. Method of measurement: Bleeding volume during field operation, blood gases, suction.;Determining the duration of surgery in the groups receiving tranexamic acid ,fibrinogen and the control group. Timepoint: End of surgery. Method of measurement: hours / minutes.;Amount of blood and blood products injected. Timepoint: End of surgery. Method of measurement: The number of units to be injected.

Secondary

MeasureTime frame
Determining the duration of surgery in the groups receiving tranexamic acid ,fibrinogen and the control group. Timepoint: End of surgery. Method of measurement: hours / minutes.;Determination of recovery time after reverse dose injection in groups receiving tranexamic acid ,fibrinogen and control group. Timepoint: End of surgery. Method of measurement: hours / minutes.;Determining the length of stay in the intensive care unit in the groups receiving tranexamic acid ,fibrinogen and the control group. Timepoint: End of surgery. Method of measurement: hours / minutes.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSogol Asgari

Shahid Beheshti University of Medical Sciences

Drasgari98429@gmail.com+98 21 5541 9005

Outcome results

None listed

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