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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101124
• Other study ID #: 270778
• Secondary ID: 2016-004246-28
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: August 2019
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Surgical Wound
• Weight Loss

Intervention

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
• 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
• Tranexamic Acid Injectable Solution
1 g of tranexamic acid administered intravenously in accordance with prevailing routines directly prior to planned surgical procedure.

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Aleris Helse

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Ausen K, Pleym H, Liu J, Hegstad S, Nordgård 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours
Secondary	AUC from 0 to 240 min	if AUC from 0 to infinity turns out to be the primary end point.	24 hours
Secondary	Maximum concentration (Cmax)	Maximal level of serum tranexamic acid in measurements	24 hours
Secondary	Timepoint for maximum serum concentration (Tmax)	Timepoint for serum tranexamic acid read from AUC	24 hours
Secondary	Elimination half-life	Reading elimination half-life from AUC	24 hours
Secondary	Adverse events	Possible adverse reactions or other complaints observed or reported by the patient - telephone interview	four weeks
Secondary	Adverse events	Possible adverse reactions or complaints observed or reported on the first postoperative day - clinical observation	1 day