NCT03101124

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Surgical Wound
• Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic Acid 25 mg/ml for wound surface moistening	Wound surface moistened with 20 ml of tranexamic acid 25 mg/ml (total dose 500 mg) prior to wound closure
DRUG	Tranexamic Acid 5 mg/ml as bolus in wound cavity	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
DRUG	Tranexamic Acid Injectable Solution	1 g of tranexamic acid administered intravenously in accordance with prevailing routines directly prior to planned surgical procedure.

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2017-04-04
• Last updated: 2019-08-19

Locations

1 site across 1 country: Norway