A Phase 4 interventional study of tranexamic acid and 0.9% NaCl in Bleeding, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-18.
Sponsored by Mahidol University · Phase 4, Interventional, and Treatment
Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few studies in laminectomy had conflicting results and varying in doses. The objective is to compare perioperative bleeding in major laminectomy between patients receive doubles doses of tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).
78 patients undergoing major laminectomy (with instrumentation or equal or more than 3 levels laminectomy) will be enrolled. We exclude patients who age over 65, anemia, allergy to tranexamic acid, history of deep vein thormbosis (DVT), ischemic heart disease (IHD), pulmonary embolism (PE), strokes, liver disease, chronic kidney disease with creatinine >2.0 mg/dl, and coagulopathy. After randomization, before induction and 3 hour after the first dose, patients will receive study drug or placebo intravenously. The standard anesthesia and monitoring will be tha same for all of the patients. Perioperative mild hypotensive technique will be used with the mean arterial pressure more than 60 mmHg and nearly the end, the blood pressure will be back to normal for the bleeding check. Hematocrit will be monitored at the begining and every two hours. Blood will be given if the hematocrit is below 30%. The perioperative fluid will be managed by anesthesiologist who will not know the patients' groups. The next morning, the hematocrit and blood creatinine will be checked and if the hematocrit is lower than 30%, blood will be given. Perioperative blood loss, total fluid and blood transfusion within 24 hours will be recorded. If there are any suspected symptoms and signs of DVT, angina, CHF, PE, strokes or other complications, the necessory investigations will be done for the definite dignosis and the appropriate treatment will be started immediately.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 78 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tranexamic acid (15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will given before induction and the second dose(15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will be given at 3 hours after the first dose.
Drug: tranexamic acid
0.9% NaCl 100 ml will be given as a placebo before induction and 3 hours after the first dose
Drug: 0.9% NaCl
Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo)
Also known as: transamine (Daiichi-Sankyo, Japan)
0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid
Also known as: NSS
perioperative blood loss
Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage
Time frame: 24 hours
perioperative blood transfusion
When the blood loss more than acceptable and the hematocrit below 30%, the packed red cell will be given.
Time frame: 24 hours
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mahidol University