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IRCT20231112060028N1 IRCT 2023-11-15 Shiraz University of Medical Sciences Intravenous Desmopressin, Tranexamic Acid, and Their Combined Impact on Intra-Operative Bleeding in Functional Endoscopic Sinus Surgery TDEFECT (TXA, DDAVP Efficacy Functional Endoscopic Clinical Trial) Evaluation of the effect of Intravenous Desmopressin, Tranexamic Acid, and their combination on intra-operative bleeding during functional endoscopic sinus surgery of adults 2023-11-12 anticipated 93 Complete https://irct.ir/trial/73689 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: The randomization method for this double-blinded randomized clinical trial will be conducted using computer-generated random numbers. The assignment of participants to the study groups will be performed in a randomized manner to ensure equal distribution among the groups. The randomization process will be carried out by an individual who is not directly involved in the recruitment or assessment of participants. Once informed consent is obtained from eligible participants, they will be assigned a unique identification number. The randomization list will be generated using a computer program, which will allocate participants to one of the ..three study groups: DDAVP group, TXA group, or combination group, Blinding description: To ensure the integrity and validity of the study, a double-blind approach will be implemented, where both the participants and the research team will be blinded to the treatment assignments. The blinding method will involve the following measures: 1. Blinded Treatment Allocation: The assignment of participants to the three study groups (DDAVP group, TXA group, and combination group) will be performed using computer-generated random numbers by an independent researcher not involved in the data collection or analysis. The treatment allocation will be concealed from the participants, surgeons, anesthesiologist, and other members of the research team who are directly involved in patient care. 2. Identical Packaging and Labeling: The DDAVP and TXA medications will be prepared and packaged in identical containers with matching labels. The containers will be indistinguishable in appearance, ensuring that neither the participants nor the healthcare providers can differentiate between the treatments. 3. Blinded Administration: The medications (DDAVP and TXA) will be administered intravenously by a nurse or healthcare provider who is not directly involved in the data collection or analysis. The administration will be performed in a separate room away from the surgical area, ensuring that the surgical team remains unaware of the specific treatment being administered. 5. Blinded Data Collection and Analysis: The collection of intraoperative and postoperative data, will be performed by research personnel who are blinded to the treatment assignments. These individuals will not have access to the treatment information during data collection, thereby preventing any potential bias in data recording. 5. Unblinding Procedures: In the case of an emergency or if there is a medical necessity to reveal the treatment assignment for a specific participant, a separate unblinding procedure will be established. This procedure will outline .the steps to be followed to maintain the blinding integrity of the study while addressing the participant's needs. 2 Condition 1: Chronic sinusitis. Condition 2: Nasal polyp. Intervention 1: Intervention group (Desmopressin Group): Patients will undergo general anesthesia and FESS as indicated under the routine standard of care. Patients in the DDAVP group will receive 0.3 μg/kg of IV DDAVP (DESMOPRESSIN INJECTION PARENTERAL 4 μg/1mL, Ferring GmbH, Switzerland), before the start of the operation. Intervention 2: Intervention group (Tranexamic Acid Group): Patients will undergo general anesthesia and FESS as indicated under the routine standard of care. Patients will receive before the operation, 15 mg/kg of IV TXA (TRANEXAMIC ACID INJECTION PARENTERAL 100 mg/1mL 5MILLILITER, Caspian Tamin Pharmaceutical Company, Iran) in the TXA group. Intervention 3: Intervention group (Desmopressin + Tranexamic Acid): Patients will undergo general anesthesia and FESS as indicated under the routine standard of care. Patients in the DDAVP group will receive the combination of 0.3 μg/kg of IV DDAVP (DESMOPRESSIN INJECTION PARENTERAL 4 μg/1mL, Ferring GmbH, Switzerland) and 15 mg/kg of IV TXA (TRANEXAMIC ACID INJECTION PARENTERAL 100 mg/1mL 5MILLILITER, Caspian Tamin Pharmaceutical Company, Iran), before the start of the operation in the combination group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ali Faramarzi
Otolaryngology Research Center, Khalili Teaching Hospital, Khalili St. Shiraz University of Medical Sciences, Shiraz, Iran. Postal code #7134814336
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3629 1417 ali_faramarzi@sums.ac.ir Shiraz University of Medical Sciences scientific Arash Farbood
Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3629 1417 farboda@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) First-time candidates of bilateral FESS due to chronic rhinosinusitis with polyp Patients should have a normal test result (CBC, PT, PTT, renal function tests, electrolytes) Patients classified as American Society of Anesthesiologists (ASA) I and ASA II 18 years 65 years Both Wegener's disease Sarcoidosis Sinonasal malignancy Bleeding disorders Known hypersensitivity to TXA or DDAVP Active venous or arterial thromboembolic disease History of seizures Renal impairment (defined as a creatinine clearance below 50 mL/min) Disseminated Intravascular Coagulation (DIC) or any coagulopathy Color vision disorders Pregnancy and breastfeeding Heart failure or other conditions needing fluid restrictions Hyponatremia or history of hyponatremia Revision surgeries Poorly controlled hypertension or cerebrovascular disease History of significant coronary artery disease or arrhythmias J32 J33 Chronic sinusitis Nasal polyp Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group (Desmopressin Group): Patients will undergo general anesthesia and FESS as indicated under the routine standard of care. Patients in the DDAVP group will receive 0.3 μg/kg of IV DDAVP (DESMOPRESSIN INJECTION PARENTERAL 4 μg/1mL, Ferring GmbH, Switzerland), before the start of the operation. Intervention group (Tranexamic Acid Group): Patients will undergo general anesthesia and FESS as indicated under the routine standard of care. Patients will receive before the operation, 15 mg/kg of IV TXA (TRANEXAMIC ACID INJECTION PARENTERAL 100 mg/1mL 5MILLILITER, Caspian Tamin Pharmaceutical Company, Iran) in the TXA group. Intervention group (Desmopressin + Tranexamic Acid): Patients will undergo general anesthesia and FESS as indicated under the routine standard of care. Patients in the DDAVP group will receive the combination of 0.3 μg/kg of IV DDAVP (DESMOPRESSIN INJECTION PARENTERAL 4 μg/1mL, Ferring GmbH, Switzerland) and 15 mg/kg of IV TXA (TRANEXAMIC ACID INJECTION PARENTERAL 100 mg/1mL 5MILLILITER, Caspian Tamin Pharmaceutical Company, Iran), before the start of the operation in the combination group. Intra-operative blood loss. Timepoint: Intra-operative and at the end of the operation. Method of measurement: The volume of blood suctioned during the operation excluding the normal volume of saline used. Surgical field bleeding score. Timepoint: Intraoperative. Method of measurement: BOEZAART grading scale for scoring surgical field bleeding. Duration of surgery. Timepoint: At the end of the operation. Method of measurement: The end of the operation minus the start of the operation. Mohammad Faramarzi, Ali Faramarzi, Arash Farbood Approved 2023-11-07 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand St. Shiraz Fars Iran (Islamic Republic of)