A Phase 3 interventional study of Tranexamic acid and Saline placebo in Bleeding Nose, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.
A written informed consent will be taken from the patients.The study involved adults of either sexes (age 18-65 years) of ASA I-II who will be listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia, with normal accepted coagulation profile and hematocrit value ≥30 %. Excluded from the study patients with chronic renal failure, liver cirrhosis, bleeding disorders, current anticoagulant therapy, pregnancy or breastfeeding, impaired color vision, severe vascular ischemia, history of venous thrombosis, pulmonary embolism, long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery, a hemoglobin (HB) concentration \<10 mg/dl or allergy to TXA.
Randomization: A random number sequence created by an internet website (http://www. random.org) will be used for patients' allocation. The random number sequence was retained in closed opaque envelopes released the day of the surgery by an independent physician not involved in the study. Patients will be assigned randomly to three groups (30 subjects each); saline placebo (Group S) and two different doses of preemptive nebulized tranexamic acid (Group T1) and (Group T2).To keep blinding, Group S will receive 2 sessions of nebulization each by 5 ml saline. Group T1 will receive one nebulization session 500 mg tranexamic acid (5 ml) and another one by 5 ml saline. Group T2 will receive 2 nebulization sessions each by 500 mg tranexamic acid (each by 5 ml)
96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.
This study's enrollment of 90 is above the median of 64 across 81 interventional studies indexed under Epistaxis.
Browse Epistaxis studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nebulized tranexamic acid 500 mg 15 minutes before operation
Drug: Tranexamic acid
Nebulized tranexamic acid 1 gm 15 minutes before operation
Drug: Tranexamic acid
Normal saline nebulization 15 minutes before operation
Other: Saline placebo
Tranexamic acid nebulization 15 minutes before sinus surgery
Also known as: Cyclokapron
Normal saline placebo nebulization 15 minutes before sinus surgery
the Modena Bleeding Score (MBS) assessing surgical field
1= No bleeding, 2=Bleeding easily controlled by suctioning, washing or packing without any significant modification or slowing of surgical procedure, 3=Bleeding slowing surgical procedure, 4=Most of the maneuvers dedicated to bleeding control and 5=Bleeding that prevents every surgical procedure except those dedicated to bleeding control
Time frame: After anesthesia induction to 60 minute
HR
Heart rate beat/min
Time frame: Intraoperative duration
MBP
Mean blood pressure mmHg
Time frame: Intraoperative duration
Anesthetic consumption
Extra doses of fentanyl and propofol and sevoflurane\>2
Time frame: Anesthesia duration
Postoperative complications
Recording any adverse effects to TXA e.g.nausea, vomiting and any visual disturbances
Time frame: After operation to 24 hour
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2021 to primary completion in Jun 2026, 60 months.
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Studies of the drug tested here: Tranexamic Acid