The Effect of The Tranexamic Acid on The Amount of Bleeding In Patients Under Surgical Mandibular Fractures

Evaluation of The Effect of The Tranexamic Acid and Placebo on The Amount of Bleeding in Patients Under Surgical Treatment of Bilateral Mandibular Fractures

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015051122204N1

Enrollment

Registered

2015-06-10

Start date

2014-08-23

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

Intraoperative bleeding. Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care

Interventions

Intervention 1: Group I: injection of 20 ml of tranexamic acid (20 mg/kg), precisely before surgery. Intervention 2: Group II: injection of 20 ml of normal salin solution (0.9%), precisely before surg

Prevention

Placebo

Group I: injection of 20 ml of tranexamic acid (20 mg/kg), precisely before surgery

Group II: injection of 20 ml of normal salin solution (0.9%), precisely before surgery

Eligibility

Sex/Gender

All

Age

20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients undergoing bilateral mandibular fractures surgery. Exclusion Criteria: Patients with subarachnoid hemorrhage; History of CVA (cerebrovascular accident definition); History of thrombosis; History of renal diseases and hematuria; Patients with bone disease; Patients with cleft lip and palate; Patients with craniofacial syndromes; History of Temporomandibular joint surgery; History of bone transplant recipient.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The amount of hemoglobin. Timepoint: Immediately before surgery and immediately after surgery. Method of measurement: Venous sampling and sent to the laboratory.;The amount of hematocrit. Timepoint: Immediately before surgery and immediately after surgery. Method of measurement: Venous sampling and sent to the laboratory.	—

Secondary

Measure	Time frame
Bleeding (By calculating the difference between pre- and postoperative hemoglobin(Hb)). Timepoint: After surgery. Method of measurement: Using the formula: CBL= BV×(Hb loss/Hb per), Hb loss = Hb pre – Hb post + t(The number of injected packed red blood cell units).;Bleeding (By calculating the difference between pre- and postoperative hematocrit(Hct)). Timepoint: After surgery. Method of measurement: Using the formula: CBL = RBCL / [(HCTper+HCTpost)/2], RBCL = BV × (Hct pre – Hct post) + 320 t.	—

Measure

Time frame

Bleeding (By calculating the difference between pre- and postoperative hemoglobin(Hb)). Timepoint: After surgery. Method of measurement: Using the formula: CBL= BV×(Hb loss/Hb per), Hb loss = Hb pre – Hb post + t(The number of injected packed red blood cell units).;Bleeding (By calculating the difference between pre- and postoperative hematocrit(Hct)). Timepoint: After surgery. Method of measurement: Using the formula: CBL = RBCL / [(HCTper+HCTpost)/2], RBCL = BV × (Hct pre – Hct post) + 320 t.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Ahmadfar

Ahvaz Jundishapur University of Medical Sciences

majid.ahmadfar@gmail.com+98 61 3222 2922

Outcome results

None listed

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