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Clinical trial

The Effect of The Use of Low Dose Tranexamic Acid on Surgeon Satisfaction, Side Effects and Complications in Endoscopic and Microscopic Ear Surgery Cases Which Are Used With Controlled Hypotension

ID
Name
2024/88
Description
By using tranexamic acid, an antifibrinolytic drug, the aim is to prevent the restriction of the field of view of the surgical field due to bleeding in middle ear microscopic and endoscopic surgery operations in which controlled hypotension is applied, and therefore the prolongation of the surgical time, and to increase surgeon satisfaction.
Trial arms
Trial start
2024-09-01
Estimated PCD
2025-05-01
Trial end
2025-06-01
Status
Not yet recruiting
Treatment
Transamine 10% IV/IM Solution for Injection
10 mg/kg tranexamic acid (Transamine 10% IV/IM Injectable Solution) will be placed into 100 cc physiological saline through the appropriate vascular access and injected within 15 minutes.
Arms:
Intervention Group (I)
Other names:
tranexamic acid
%0.9 Saline
100 cc %0.9 Normal Saline will be injected through the appropriate vascular access within 15 minutes
Arms:
Control Group (C)
Other names:
Physiological Saline, %0.9 NaCl
Size
100
Primary endpoint
Boezaart et al grading scale
2-3 hours
Surgeon Satisfaction Score
2-3 hours
Eligibility criteria
Inclusion Criteria: * Individuals between the ages of 18-65 * Individuals with ASA I (no additional disease) or ASA II (mild systemic disease) * Those who do not have a disease such as thrombophilia or bleeding diathesis will be included in the study Exclusion Criteria: * Patients with ASA III (those with uncontrolled chronic disease) or above * Patients with cardiovascular disease, congestive heart failure, coronary artery disease, cerebrovascular insufficiency, renal or hepatic failure * Patients with thrombophilia, bleeding diathesis, coagulation defects * Pregnant patients * Those with a history of any allergic reaction to tranexamic acid and its derivatives will be excluded from the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-05-30

1 organization

2 products

1 indication

Organization
TC Erciyes University
Product
Transamine 10%
Indication
Middle Ear Disease
Product
0.9% Saline