Tranexamic acid is a drug that prevents clotted blood from dissolving and hence reduces bleeding. It is routinely given intravenously in many surgical situations where there is a risk of major bleeding. Concerns regarding possible adverse effects from intravenous use prevents a more widespread use, even in smaller surgeries. Topical application - using the drug directly on the wound surface- may give a higher concentration at the site of bleeding but a lower concentration in the rest of the body, and hence a lower risk of adverse effects. Here it will be investigated to what extent a defined dose of the drug is absorbed systemically - into the blood stream - when it is applied topically. This will then be compared to the concentration in the blood stream when administered intravenously. Blood samples will be obtained at defined time intervals after administration from patients receiving topical and patients receiving intravenous administration of the same single dose of tranexamic acid. Will less of the drug enter the blood stream if it is applied directly to the wound?
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
36
Wound surface moistened with 20 ml of tranexamic acid 25 mg/ml (total dose 500 mg) prior to wound closure
200 ml of tranexamic acid 5 mg/ml (total dose 1 g) as a bolus instilled into the wound cavity after wound closure, which will remain in the cavity until the activation of drains one hour later
1 g of tranexamic acid administered intravenously in accordance with prevailing routines directly prior to planned surgical procedure.
St Olavs Hospital
Trondheim, Norway
Serum concentration of tranexamic acid
as described by the Area Under the (time-concentration) Curve (AUC) from 0 to infinity, alternatively from 0 to 240 minutes if drug levels after 24 hours do not allow for such extrapolation
Time frame: 24 hours
AUC from 0 to 240 min
if AUC from 0 to infinity turns out to be the primary end point.
Time frame: 24 hours
Maximum concentration (Cmax)
Maximal level of serum tranexamic acid in measurements
Time frame: 24 hours
Timepoint for maximum serum concentration (Tmax)
Timepoint for serum tranexamic acid read from AUC
Time frame: 24 hours
Elimination half-life
Reading elimination half-life from AUC
Time frame: 24 hours
Adverse events
Possible adverse reactions or other complaints observed or reported by the patient - telephone interview
Time frame: four weeks
Adverse events
Possible adverse reactions or complaints observed or reported on the first postoperative day - clinical observation
Time frame: 1 day
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