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OpenTrials
Completed

NCT Number: NCT03101124

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

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid 25 mg/ml for wound surface moistening

Drug

Wound surface moistened with 20 ml of tranexamic acid 25 mg/ml (total dose 500 mg) prior to wound closure

Other names: Cyclokapron

Tranexamic Acid 5 mg/ml as bolus in wound cavity

Drug

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

Other names: Cyclokapron

Tranexamic Acid Injectable Solution

Drug

1 g of tranexamic acid administered intravenously in accordance with prevailing routines directly prior to planned surgical procedure.

Other names: Cyclokapron

Primary outcomes

  1. Serum concentration of tranexamic acid

    Time frame: 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 outcomes

  1. AUC from 0 to 240 min

    Time frame: 24 hours

    if AUC from 0 to infinity turns out to be the primary end point.

  2. Maximum concentration (Cmax)

    Time frame: 24 hours

    Maximal level of serum tranexamic acid in measurements

  3. Timepoint for maximum serum concentration (Tmax)

    Time frame: 24 hours

    Timepoint for serum tranexamic acid read from AUC

  4. Elimination half-life

    Time frame: 24 hours

    Reading elimination half-life from AUC

  5. Adverse events

    Time frame: four weeks

    Possible adverse reactions or other complaints observed or reported by the patient - telephone interview

  6. Adverse events

    Time frame: 1 day

    Possible adverse reactions or complaints observed or reported on the first postoperative day - clinical observation

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Aleris Helse

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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