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IRCT20231124060157N1 IRCT 2024-10-05 Mashhad University of Medical Sciences 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. 2024-02-18 anticipated 40 Complete https://irct.ir/trial/79050 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Method: The study will use block randomization to ensure an equal number of participants in each group. In each block, four participants will be randomly assigned to the different intervention and control groups. Unit of Randomization: The unit of randomization is individual; each patient is individually assigned to one of the groups. Stratified Randomization: There is no use of stratified randomization in this study. Randomization Tool: The randomization sequence will be generated using a table of random numbers provided by the software randomization.com. This tool generates the random sequence for allocating participants to the groups. Generation of Random Sequence: The random sequence will be created using randomization.com, based on blocks of four. The sequence will be stored in sealed envelopes, and for each patient, an envelope will be opened to assign the patient to one of the groups. Allocation Concealment: Allocation concealment will be maintained using sealed opaque envelopes. Each envelope contains a code that indicates which group the patient will be assigned to (intervention or control). These envelopes remain sealed until the patient is enrolled in the study and opened by blinded investigators, Blinding description: A pharmacist is responsible for preparing the drugs and materials used, and all medications are prepared in containers or syringes labeled only with the patient’s number. This ensures that neither the treatment team nor the patient knows whether the solution contains tranexamic acid or a placebo. Patients are randomly assigned to one of the groups (intervention or control) without knowing which group they belong to. Postoperative outcomes and complications are assessed by independent evaluators who are blinded to the group allocation of the patients. 3 Condition 1: Postprocedural shock. Condition 2: Neoplasm of uncertain behavior of bone and articular cartilage. Condition 3: Malignant neoplasm of head, face and neck. 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 acid in 30 cc normal saline (1 gram in 30 cc normal saline). Intervention 3: Control group: No medication administered. Yes - There is a plan to make this available What will be shared: The data collected in this study include non-identifiable individual participant information, demographic data, pre- and post-operative bleeding levels, blood test results (CBC), and information related to interventions and postoperative outcomes. All data are stored in a manner that ensures participant anonymity. Raw data may be shared after appropriate de-identification procedures are implemented. Data related to the study's primary outcome, including post-operative bleeding levels and relevant test results, may be shared. However, access to sensitive personal and medical data is restricted to the research team and will be provided only under strict confidentiality protocols. When: 6 months after publishing results To whom: The data from this study will be available only to researchers working at academic and scientific institutions involved in research related to the study’s topic. Data requests must be submitted by verified researchers from reputable institutions and will be evaluated based on their scientific and research objectives. Individuals working in industry or non-scientific organizations must provide sufficient justification and clear research goals in order to request access to the data. Such requests will be considered by the research team, ensuring compliance with ethical standards and data confidentiality protocols. In all cases, adherence to confidentiality principles and the de-identification of individual participant data is mandatory. Conditions: The use of data and documents from this study is permitted only for scientific and research purposes under the following conditions: Specific Research Objectives: Applicants must provide clearly defined research objectives related to the study's topic. These objectives should align with advancing knowledge in the field of head and neck surgeries and the use of tranexamic acid. Permitted Analyses: Permitted analyses include standard statistical analyses to assess postoperative bleeding, comparisons between intervention and control groups, and evaluation of postoperative complications. Any analysis outside the study’s original scope requires approval from the research team. No Commercial Use: The data and documents are solely for non-commercial research purposes. Commercial use of the data is strictly prohibited. Confidentiality and Data Security: Non-identifiable individual data must be handled with confidentiality and in accordance with data security protocols. All usage must ensure the privacy and anonymity of the study participants. Formal Request Submission: Requests for data access must be formally submitted, including the applicant’s full details, research goals, and a clear description of how the data will be used. Requests should be approved by a recognized academic or scientific institution. Limited to Secondary Analyses: Data and documents may be used for secondary analyses, but any publication or public dissemination of results must be approved in writing by the original research team. Ethical Approval: Any further use of the data must comply with ethical research principles and receive approval from the relevant ethics committees. Where to obtain: Responsible for Study Inquiries: Dr. Sina Samiei Rad (phone number: +989921545609) How to obtain: The request must first be sent to the project response officer, Dr. Sina Samiei Rad, at the email address samiieerads991@mums.ac.ir. Within one week of submitting the request, if there are no legal restrictions, the documents will be made accessible. Comments:
public Sina Samieerad
Azadi squ.
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3800 2202 SamieeRadS991@mums.ac.ir Mashhad University of Medical Sciences scientific Sina Samieerad
Azadi squ.
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3800 2202 SamieeRadS991@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients undergoing head and neck surgeries, including unilateral head and neck cancer surgery, unilateral neck dissection, mandible resection, thyroidectomy, and parotidectomy. 18 years 80 years Both 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. T81.1 D48.0 C76.0 Postprocedural shock Neoplasm of uncertain behavior of bone and articular cartilage Malignant neoplasm of head, face and neck Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group (A): Recipients of 20 mg/kg intravenous tranexamic acid in 100 cc normal saline. Intervention group (B): Recipients of 25 mg/ml topical tranexamic acid in 30 cc normal saline (1 gram in 30 cc normal saline). Control group: No medication administered. 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. Mashhad University of Medical Sciences Approved 2022-05-31 Mashhad university of medical sciences Danseshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)