Evaluating the effect of Prophylactic low-dose of Tranexamic Acid (TXA) in spinal fixation-surgery

Reduction of bleeding during the spinal fixation-surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT138805152193N2

Enrollment

Registered

2009-11-10

Start date

2009-01-01

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 Prophylactic Tranexamic Acid for a reduction on bleeding in spinal fixation-surgery. Haemorrhagic condition, unspecified

Interventions

Normal saline, with the same volume of active during induction of anesthesia and surgery

Intervention 1: Tranexamic Acid, 10 mg/kg during induction of anesthesia and then 1 kg/mg/hr during the surgery. Intervention 2: Normal saline, with the same volume of active during induction of anest

Treatment - Drugs

Placebo

Tranexamic Acid, 10 mg/kg during induction of anesthesia and then 1 kg/mg/hr during the surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: candidates to the spinal fixation surgery, agreed to participateor Exclusion criteria: history of abnormal bleeding, platelet less than 150 thousands, history of Thrombosis, presence of severe hypersensitivity, consumption of interfering drugs with blood Hemostasis, presence of uncontrollable high blood pressure (PB>160/90) or overweight (EMI>30)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Bleeding volume. Timepoint: During and after the surgery. Method of measurement: Measuring collected gauzes by digital scale and using a device called Beex container which prevents Radio Opaque gauzes(4*4) from steaming and the bleeding volume is measured based on cc.;Volume of blood transfusions (blood products). Timepoint: During and after the surgery. Method of measurement: Number of transfused blood bags.	—

Measure

Time frame

Bleeding volume. Timepoint: During and after the surgery. Method of measurement: Measuring collected gauzes by digital scale and using a device called Beex container which prevents Radio Opaque gauzes(4*4) from steaming and the bleeding volume is measured based on cc.;Volume of blood transfusions (blood products). Timepoint: During and after the surgery. Method of measurement: Number of transfused blood bags.

—

Secondary

Measure	Time frame
Level of Fibrinogen. Timepoint: Before and after the operation, 24 and 48 hours after the surgery. Method of measurement: Measuring blood coagulation time.;PT. Timepoint: Before and after the operation, 24 and 48 hours after the surgery. Method of measurement: Measuring blood coagulation time.;Hemodynamic (stable cardiovascular condition of the patient). Timepoint: During and after the surgical operation. Method of measurement: The amount of consumed fluids and blood products.;Complete blood cell count. Timepoint: Before and after the operation, 24 and 48 hours after the surgery. Method of measurement: CBC.	—

Measure

Time frame

Level of Fibrinogen. Timepoint: Before and after the operation, 24 and 48 hours after the surgery. Method of measurement: Measuring blood coagulation time.;PT. Timepoint: Before and after the operation, 24 and 48 hours after the surgery. Method of measurement: Measuring blood coagulation time.;Hemodynamic (stable cardiovascular condition of the patient). Timepoint: During and after the surgical operation. Method of measurement: The amount of consumed fluids and blood products.;Complete blood cell count. Timepoint: Before and after the operation, 24 and 48 hours after the surgery. Method of measurement: CBC.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Majid Reza Farrokhi

Shiraz Neurosciences Research Center, Shiraz University of Medical Sciences

farokhim@sums.ac.ir, farrokhim_drmr@yahoo.com+98 71 1623 4508

Outcome results

None listed

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