Tranexamic Acid in bleeding during burn surgery

Evaluation of the effect of intravenous tranexamic acid on bleeding during burn surgery: a double blinded clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210524051384N8

Enrollment

Registered

2022-10-25

Start date

2022-11-22

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Burn Injury. T81.0

Interventions

Intervention 1: Severe burn patients with good hemodynamic status enter the operating room and undergo anesthesia. In the ß group (receiving 10mg/kg tranexamic acid infusion before surgery) before ind

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: patients age between 18 and 50 severe burn (TBSA>20%) candidate for burn surgery

Exclusion criteria

Exclusion criteria: history of cardiovascular disease Liver or kidney injury pregnancy or lactating occular pathologies different coagulopathies history of allergy to Tranexamic acid

Design outcomes

Primary

Measure	Time frame
Bleeding volume during burn surgery. Timepoint: During surgery. Method of measurement: 1. Blood in the suction machine.2. For each simple surgical gas that is completely impregnated with blood, 20 cc and 40 cc of bleeding will be calculated for each longaze that is completely impregnated with blood.3. The amount of bleeding in the field of surgery: This amount will be expressed according to the estimates of the surgeon and anesthesiologist. In the ninth edition of the Burn Overall Care Book published in 2018, Herndon et al. presented an improved version of the Gross formula first used in 1983, in which the rate of in-operation bleeding is calculated in three main sections. In the first section, the expected blood volume in the patient is calculated. The second section is the fraction of lost blood, which is calculated based on hematocrit before and after surgery. The third section is the amount of volume transferred to the patient during surgery to consider the effects of fluid therapy and its progress effects during surgery on the amount of bleeding. It should be noted that since there is no physician's opinion and the results are expressed subjectively, it will have the lowest bias. Therefore, the main primary outcome in this study is the result of the above formula in CC.	—

Measure

Time frame

Bleeding volume during burn surgery. Timepoint: During surgery. Method of measurement: 1. Blood in the suction machine.2. For each simple surgical gas that is completely impregnated with blood, 20 cc and 40 cc of bleeding will be calculated for each longaze that is completely impregnated with blood.3. The amount of bleeding in the field of surgery: This amount will be expressed according to the estimates of the surgeon and anesthesiologist. In the ninth edition of the Burn Overall Care Book published in 2018, Herndon et al. presented an improved version of the Gross formula first used in 1983, in which the rate of in-operation bleeding is calculated in three main sections. In the first section, the expected blood volume in the patient is calculated. The second section is the fraction of lost blood, which is calculated based on hematocrit before and after surgery. The third section is the amount of volume transferred to the patient during surgery to consider the effects of fluid therapy and its progress effects during surgery on the amount of bleeding. It should be noted that since there is no physician's opinion and the results are expressed subjectively, it will have the lowest bias. Therefore, the main primary outcome in this study is the result of the above formula in CC.

—

Secondary

Measure	Time frame
Blood transfusion. Timepoint: during and in the 24hours of surgery. Method of measurement: packed cells received.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactmohammadreza mobayen

Rasht University of Medical Sciences

maziar.mobayen@gmail.com+98 13 3336 8540

Outcome results

None listed

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