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

St. Olavs Hospital

Status and phase: Completed; Phase 2

Conditions: Surgical Wound; Bleeding

Treatments: Drug: Tranexamic Acid 5 mg/ml as bolus in wound cavity; Drug: Tranexamic Acid 25 mg/ml for wound surface moistening; Drug: Tranexamic Acid Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03101124

2016-004246-28 (EudraCT Number)

270778

Details and patient eligibility

About

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?

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

abdominoplasty moistening

Experimental group

Description:

Tranexamic Acid 25 mg/ml for wound surface moistening prior to wound closure

Treatment:

Drug: Tranexamic Acid 25 mg/ml for wound surface moistening

abdominoplasty bolus

Experimental group

Description:

Tranexamic Acid 5 mg/ml as bolus in wound cavity after wound closure

Treatment:

Drug: Tranexamic Acid 5 mg/ml as bolus in wound cavity

preoperative intravenous administration

Active Comparator group

Description:

Tranexamic Acid Injectable Solution administered before hip replacement surgery

Treatment:

Drug: Tranexamic Acid Injectable Solution