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

Phase 2

Completed

• Conditions: Surgical Wound; Bleeding
• Interventions: Drug: Tranexamic Acid 5 mg/ml as bolus in wound cavity; Drug: Tranexamic Acid Injectable Solution; Drug: Tranexamic Acid 25 mg/ml for wound surface moistening

• Registration Number: NCT03101124
• Lead Sponsor: St. Olavs Hospital

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-04
• Study Start: 2017-05-01
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-15
• Last Update Posted: 2019-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
abdominoplasty bolus	Tranexamic Acid 5 mg/ml as bolus in wound cavity	Tranexamic Acid 5 mg/ml as bolus in wound cavity after wound closure
preoperative intravenous administration	Tranexamic Acid Injectable Solution	Tranexamic Acid Injectable Solution administered before hip replacement surgery
abdominoplasty moistening	Tranexamic Acid 25 mg/ml for wound surface moistening	Tranexamic Acid 25 mg/ml for wound surface moistening prior to wound closure

Primary Outcome Measures

Name	Time	Method
Serum concentration of tranexamic acid	24 hours	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

Secondary Outcome Measures

Name	Time	Method
Timepoint for maximum serum concentration (Tmax)	24 hours	Timepoint for serum tranexamic acid read from AUC
AUC from 0 to 240 min	24 hours	if AUC from 0 to infinity turns out to be the primary end point.
Maximum concentration (Cmax)	24 hours	Maximal level of serum tranexamic acid in measurements
Elimination half-life	24 hours	Reading elimination half-life from AUC
Adverse events	1 day	Possible adverse reactions or complaints observed or reported on the first postoperative day - clinical observation

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway