Clinical trial NCT03101124: Serum Concentration of Tranexamic Acid After Topical Administration in Massive Weight Loss Skin Reducing Surgery
Official title: Serum Concentration of Tranexamic Acid After Topical Administration in Massive Weight Loss Skin Reducing Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgical Wound
Bleeding
Keywords: Hemostasis, Surgical
Tranexamic Acid
Antifibrinolytic Agents
Administration, Cutaneous
Administration, Intravenous
Administration, Topical
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Aleris Helse
First posted: 2017-04-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 12 participants will be included in each of 3 groups: wound moistening group (skin reduction surgery), wound bolus group (after skin reduction surgery), and (for comparison) a group getting usual intravenous tranexamic acid before orthopedic surgery. It is not possible to conduct a formal power calculation, as it is completely unknown which concentrations could be expected after topical use; however, these concentrations are expected to be considerably lower than after intravenous use. Consequently, it is expected that the AUC values in all subjects in the topical (skin reducing surgery) group are far lower than in all subjects in the intravenous (orthopaedic surgery) group. 12 subjects is therefor considered an appropriate number.
Primary purpose: PREVENTION

Brief summary: 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?


Eligibility criteria: Inclusion Criteria:

* planned for major skin reduction surgery (abdominoplasty/panniculectomy) after massive weight loss, or
* planned for orthopaedic hip replacement surgery

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy to tranexamic acid/Cyklokapron®
* ongoing or former thromboembolic event
* known kidney failure, as defined by estimated glomerular filtration rate (eGFR)\<60 ml/min

Primary outcomes:
measure: Serum concentration of tranexamic acid
timeFrame: 24 hours
Secondary outcomes:
measure: AUC from 0 to 240 min
timeFrame: 24 hours
measure: Maximum concentration (Cmax)
timeFrame: 24 hours
measure: Timepoint for maximum serum concentration (Tmax)
timeFrame: 24 hours
measure: Elimination half-life
timeFrame: 24 hours
measure: Adverse events
timeFrame: four weeks
measure: Adverse events
timeFrame: 1 day
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St Olavs University Hospital
name: Birger Henning Endreseth, MD PhD
role: STUDY_DIRECTOR
References:
citation: Ausen K, Pleym H, Liu J, Hegstad S, Nordgard HB, Pavlovic I, Spigset O. Serum Concentrations and Pharmacokinetics of Tranexamic Acid after Two Means of Topical Administration in Massive Weight Loss Skin-Reducing Surgery. Plast Reconstr Surg. 2019 Jun;143(6):1169e-1178e. doi: 10.1097/PRS.0000000000005620.