Evaluation of the effect of topical versus intravenous tranexamic acid on reducing bleeding in head and neck surgeries

Comparison of the effects of topical versus intravenous tranexamic acid on reducing bleeding in patients undergoing head and neck surgeries: A double-blind clinical trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231124060157N1

Enrollment

Registered

2024-10-05

Start date

2024-02-18

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Condition 1: Postprocedural shock. Condition 2: Neoplasm of uncertain behavior of bone and articular cartilage. Condition 3: Malignant neoplasm of head, face and neck. Postprocedural shock Neoplasm of uncertain behavior of bone and articular cartilage Malignant neoplasm of head, face and neck

Interventions

Intervention 1: Intervention group (A): Recipients of 20 mg/kg intravenous tranexamic acid in 100 cc normal saline. Intervention 2: Intervention group (B): Recipients of 25 mg/ml topical tranexamic ac

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients undergoing head and neck surgeries, including unilateral head and neck cancer surgery, unilateral neck dissection, mandible resection, thyroidectomy, and parotidectomy.

Exclusion criteria

Exclusion criteria: Patients with a history of uncontrolled bleeding or severe coagulation disorders. Patients with a known allergy to tranexamic acid. Patients with severe renal impairment (creatinine > 1.2). Patients with severe liver disease. Patients with recent use of anticoagulant medications (heparin or warfarin). Patients with a history of prior surgery or radiotherapy in the neck region. Patients with severe peripheral vascular diseases. Patients with a recent history of stroke or cardiovascular diseases.

Design outcomes

Primary

Measure	Time frame
Post-operating bleeding. Timepoint: The amount of postoperative bleeding is measured at the following time points:Before the surgery (to establish baseline hemoglobin and platelet levels).During the first 24 hours after surgery (blood collection from the drain).Every subsequent 24 hours until the drain is removed (typically when the output is less than 20 milliliters per day for two consecutive days). Method of measurement: Postoperative bleeding is measured using the gravimetry technique (weighing the blood drained from surgical drains). In addition, the volume of blood collected in the suction bag is measured. Hemoglobin and platelet levels are recorded before and after surgery using a complete blood count (CBC) test.	—

Measure

Time frame

Post-operating bleeding. Timepoint: The amount of postoperative bleeding is measured at the following time points:Before the surgery (to establish baseline hemoglobin and platelet levels).During the first 24 hours after surgery (blood collection from the drain).Every subsequent 24 hours until the drain is removed (typically when the output is less than 20 milliliters per day for two consecutive days). Method of measurement: Postoperative bleeding is measured using the gravimetry technique (weighing the blood drained from surgical drains). In addition, the volume of blood collected in the suction bag is measured. Hemoglobin and platelet levels are recorded before and after surgery using a complete blood count (CBC) test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSina Samieerad

Mashhad University of Medical Sciences

SamieeRadS991@mums.ac.ir+98 51 3800 2202

Outcome results

None listed

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