None listed
Conditions
Brief summary
New treatment option for post-surgery bleeding in ENT surgery patients undergoing sinonasal surgery. The potential treatment is Oral Tranexamic Acid (TXA) which has been used in other surgical disciplines to control post-surgery bleeding. The purpose of this study is to determine the effectiveness of oral TXA in preventing postoperative bleeding following sinonasal surgery and thereby decreasing discomfort and complications in the post operative period. This research clinical trial is a placebo-controlled drug trial. Both the treatment and placebo will look identical and participant nor the trial doctors will know which group you have been assigned to. The medication will be administered from 8am day 1 post-surgery as capsules. Two capsules will be administered 3 times a day for 3 days. Each capsule contains either 500mg TXA or placebo. Participants are allocated in a random 2 :1 ratio, thereby there will be 2 out of 3 chances of receiving the TXA study medication and 1 in 3 chances of being allocated placebo.
Interventions
1g of Tranexamic Acid will be delivered intraoperatively intravenously as per standard care. This will then be followed by the investigational treatment of 2 x 500mg capsules of Tranexamic Acid which will be self-administered administered orally at 3 times a day for 72 hours postoperatively from 8am on the first postoperative day. Participants will administer capsules themselves at home. Each participant will be given a medication sheet to complete at home and will be educated on how to complete
1g of Tranexamic Acid will be delivered intraoperatively intravenously as per standard care. This will then be followed by the investigational treatment of 2 x 500mg capsules of Tranexamic Acid which will be self-administered administered orally at 3 times a day for 72 hours postoperatively from 8am on the first postoperative day. Participants will administer capsules themselves at home. Each participant will be given a medication sheet to complete at home and will be educated on how to complete this form . On the form they will record time and date of each dose and there is a space to note any problems with taking each dose e.g. missed /unable to swallow/vomited after taking. Bottle will be returned along with medication record form to study team at next clinic visit and return will be recorded in the medication delegation log. Any unused medication will be recorded or any episode where patient has recorded on medication sheet that they were unable to swallow tablet or vomited after taking tablet will be recorded to measure overall compliance .
Sponsors
Metro North Hospital and Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients greater than or equal to 18 years to patients less than or equal to 80 years 2. Undergoing sinus and / or nasal surgery (septoplasty, turbinoplasty, rhinoplasty, mini- Functional Endoscopic Sinus surgery) 3. Ability to consent to participation
Exclusion criteria
Exclusion criteria 1. Patients less than or equal to 17 years and patients greater than or equal to 81 years 2. Patients with active thromboembolic disease or risk of thrombus as per clinical investigator 3. Patients with known stage 3-5 renal failure 4. Patients with history of uncontrolled epilepsy 5. Participants who are unable to provide informed consent. 6. Participants who are pregnant, breast feeding or planning to become pregnant. 7. Women of childbearing potential who are not willing to use double barrier method of contraception during the study, that is: use of contraceptive pill or intra uterine device (IUD) or similar and Condoms 8. Currently on any antiplatelet or anticoagulant medications 9. Have any known hypersensitive reactions to TXA 10. Have any significant medical comorbidity which the investigator would consider a contraindication to use of TXA. 11. The participant does not agree to comply with or is unable to meet all study requirements for the duration of the study period. 12. Participants deemed by the investigator to be unsuitable for participation in the study.
Outcome results
None listed