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

NCT ID: NCT03101124

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-02-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

abdominoplasty moistening

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

Group Type: EXPERIMENTAL

Tranexamic Acid 25 mg/ml for wound surface moistening

Intervention Type: DRUG

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

abdominoplasty bolus

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

Group Type: EXPERIMENTAL

Tranexamic Acid 5 mg/ml as bolus in wound cavity

Intervention Type: 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

preoperative intravenous administration

Tranexamic Acid Injectable Solution administered before hip replacement surgery

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid Injectable Solution

Intervention Type: DRUG

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

Interventions

Tranexamic Acid 25 mg/ml for wound surface moistening

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

Intervention Type: DRUG

Tranexamic Acid 5 mg/ml as bolus in wound cavity

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

Intervention Type: DRUG

Tranexamic Acid Injectable Solution

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

Intervention Type: DRUG

Other Intervention Names

Cyclokapron; Cyclokapron; Cyclokapron

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aleris Helse

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birger Henning Endreseth, MD PhD

Role: STUDY_DIRECTOR

St. Olavs University Hospital

Locations

St Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 31136475 (View on PubMed)

Other Identifiers

2016-004246-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

270778

Identifier Type: -

Identifier Source: org_study_id