Serum Concentration of Tranexamic Acid After Topical Administration in Massive Weight Loss Skin Reducing Surgery

• Status: Completed
• Trial end date: 2018-02-28
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Olavs Hospital
• Collaborator: Aleris Helse
• Treatments: Tranexamic Acid

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