]>
IRCT20150420021869N1 IRCT 2018-03-04 Esfahan University of Medical Sciences Tranexamic acid in percutaneous nephrolithotomy Evaluation of the Efficacy of Tranexamic Acid in Reducing Blood Loss in Percutaneous Nephrolithotomy (PCNL) 2016-09-10 anticipated 120 Complete https://irct.ir/trial/29228 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Study population was randomized into two groups: those who received tranexamic acid (case group) and those who received placebo (control group). Patients in case group, received 1 gr of tranexamic acid intravenously at the initiation of the procedure, continued by IV infusion of 1 gr tranexamic acid at 8 hourly intervals for the first 48 hours after surgery to reach maximum total dose of 6 gr. For allocation of the participants, a computer-generated list of random numbers was used. Allocation concealment was assured using opaque, sealed envelopes, Blinding description: Allocation concealment was assured using opaque, sealed envelopes. Anesthesia technician received the envelope and administered either tranexamic acid or normal saline prior to the procedure. The patient was given general anesthesia and was unaware of the received treatment and remained blinded after surgery. Two envelopes with the same information about treatment allocation were created. The second envelope was given to the nurse for postoperative drug administration. 3 Renal stone, bleeding, percutaneous nephrolithotomy. Intervention 1: Intervention group: tranexamic acid (TRANEXIP, Caspian Tamin Pharmaceutical Company, Iran) which is an antifibrinolytic drug and inhibits plasminogen activation;10 mL of 100 mg/mL injectable solution per dose administered intravenously and repeated at 8 hourly intervals to reach maximum dose of 6 gr. Intervention 2: Control group: placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Farshad Gholipour
Mardavij
Isfahan Iran (Islamic Republic of) 8168814193 +98 31 3669 7898 farshad.gholipoor@gmail.com Esfahan University of Medical Sciences scientific Farshad Gholipour
Mardavij
Isfahan Iran (Islamic Republic of) 8168814193 +98 31 3669 7898 farshad.gholipoor@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 years of age with renal stone Serum creatinin level of 1.5 mg/dL or less 18 years no limit Both history of allergy to tranexamic acid Ongoing arterial or venous thrombosis Creatinine level of more than 1.5 mg/dL Acquired defective color vision Subarachnoid hemorrhage Concurrent use of oral contraceptives N20.0 Calculus of kidney Treatment - Drugs Treatment - Drugs Intervention group: tranexamic acid (TRANEXIP, Caspian Tamin Pharmaceutical Company, Iran) which is an antifibrinolytic drug and inhibits plasminogen activation;10 mL of 100 mg/mL injectable solution per dose administered intravenously and repeated at 8 hourly intervals to reach maximum dose of 6 gr. Control group: placebo Hemoglobin drop. Timepoint: Prior to surgery, 4 hours after surgery, post-op days one and two. Method of measurement: Blood sample examination. Number of transfusions. Timepoint: Postoperative days. Method of measurement: Checklist. Postoperative length of stay. Timepoint: Postoperative days. Method of measurement: Checklist. Drug adverse effect. Timepoint: Postoperative days. Method of measurement: Checklist. Esfahan University of Medical Sciences Approved 2017-02-02 Ethics committee of Isfahan University of Medical Sciences Hezarjerib Boulvard Isfahan Isfehan Iran (Islamic Republic of)