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Surgical WoundPhase 2NCT03101124

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

A Phase 2 study testing Tranexamic Acid 25 mg/ml for wound surface moistening, Tranexamic Acid 5 mg/ml as bolus in wound cavity and Tranexamic Acid Injectable Solution in people with Surgical Wound and Bleeding, run by St. Olavs Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Wound, Bleeding
What is being tested?
Tranexamic Acid 25 mg/ml for wound surface moistening, Tranexamic Acid 5 mg/ml as bolus in wound cavity and Tranexamic Acid Injectable Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteNorway
Study dates
1 May 2017to 28 Feb 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • planned for major skin reduction surgery (abdominoplasty/panniculectomy) after massive weight loss, or
  • planned for orthopaedic hip replacement surgery

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Norway1 site

  • St Olavs Hospital

    Trondheim

Other trials in Norway

About this study

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?

Being tested
Tranexamic Acid 25 mg/ml for wound surface moistening, Tranexamic Acid 5 mg/ml as bolus in wound cavity, Tranexamic Acid Injectable Solution
Keywords
Hemostasis, Surgical, Tranexamic Acid, Antifibrinolytic Agents, Administration, Cutaneous, Administration, Intravenous, Administration, Topical
Medical subject headings
Surgical Wound, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic Acid 25 mg/ml for wound surface moisteningDrug

    Also called Cyclokapron

    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 cavityDrug

    Also called Cyclokapron

    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 SolutionDrug

    Also called Cyclokapron

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

Study groups in NCT03101124
Study groupRoleWhat they receive
abdominoplasty moisteningExperimentalTranexamic Acid 25 mg/ml for wound surface moistening prior to wound closure
Receives: Drug: Tranexamic Acid 25 mg/ml for wound surface moistening
abdominoplasty bolusExperimentalTranexamic Acid 5 mg/ml as bolus in wound cavity after wound closure
Receives: Drug: Tranexamic Acid 5 mg/ml as bolus in wound cavity
preoperative intravenous administrationActive comparatorTranexamic Acid Injectable Solution administered before hip replacement surgery
Receives: Drug: Tranexamic Acid Injectable Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 hours

Secondary outcomes (6)

  1. AUC from 0 to 240 min

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

    Measured: 24 hours

  2. Maximum concentration (Cmax)

    Maximal level of serum tranexamic acid in measurements

    Measured: 24 hours

  3. Timepoint for maximum serum concentration (Tmax)

    Timepoint for serum tranexamic acid read from AUC

    Measured: 24 hours

  4. Elimination half-life

    Reading elimination half-life from AUC

    Measured: 24 hours

  5. Adverse events

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

    Measured: four weeks

  6. Adverse events

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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start1 May 2017
  3. Primary completion28 Feb 2018
  4. Study completion28 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
12 participants will be included in each of 3 groups: wound moistening group (skin reduction surgery), wound bolus group (after skin reduction surgery), and (for comparison) a group getting usual intravenous tranexamic acid before orthopedic surgery. It is not possible to conduct a formal power calculation, as it is completely unknown which concentrations could be expected after topical use; however, these concentrations are expected to be considerably lower than after intravenous use. Consequently, it is expected that the AUC values in all subjects in the topical (skin reducing surgery) group are far lower than in all subjects in the intravenous (orthopaedic surgery) group. 12 subjects is therefor considered an appropriate number.
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03101124
Sponsor's protocol ID
270778
Other IDs
2016-004246-28, 2016
Status last verified
Aug 2019
First submitted
30 Mar 2017
Last updated
19 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ausen K, Pleym H, Liu J, Hegstad S, Nordgard 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(6):1169e-1178e. doi: 10.1097/PRS.0000000000005620.

    PubMed 31136475

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tranexamic Acid 25 mg/ml for wound surface moistening, Tranexamic Acid 5 mg/ml as bolus in wound cavity and Tranexamic Acid Injectable Solution in people with Surgical Wound and Bleeding, run by St. Olavs Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum concentration of tranexamic acid (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03101124, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.

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