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

NCT03101124 | Completed Phase 2 DMC

• 2 other identifiers: 2707782016-004246-28
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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?

Conditions

Surgical Wound; Bleeding

Keywords

Hemostasis, Surgical; Tranexamic Acid; Antifibrinolytic Agents; Administration, Cutaneous; Administration, Intravenous; Administration, Topical

Outcome Measures

Primary Outcomes (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

  24 hours

Secondary Outcomes (6)

• AUC from 0 to 240 min

  24 hours

• Maximum concentration (Cmax)

  24 hours

• Timepoint for maximum serum concentration (Tmax)

  24 hours

• Elimination half-life

  24 hours

• Adverse events

  four weeks

Study Arms (3)

abdominoplasty moistening

EXPERIMENTAL

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

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

abdominoplasty bolus

EXPERIMENTAL

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

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

preoperative intravenous administration

ACTIVE COMPARATOR

Tranexamic Acid Injectable Solution administered before hip replacement surgery

Drug: Tranexamic Acid Injectable Solution

Interventions

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

Also known as: Cyclokapron

abdominoplasty moistening

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

Also known as: Cyclokapron

abdominoplasty bolus

Tranexamic Acid Injectable Solution DRUG

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

Also known as: Cyclokapron

preoperative intravenous administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Aleris Helse: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 31136475 RESULT

MeSH Terms

Conditions

Surgical Wound; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Birger Henning Endreseth, MD PhD

  St. Olavs University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 4, 2017
• Study Start: May 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)