Tranexamic Acid During Excisional Burn Surgery (TRANEX)

March 12, 2024 updated by: Maasstad Hospital
The purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a double-blinded, randomized placebo-controlled trial. After informed consent patients will be randomized in either the placebo or the tranexamic acid group (1500 mg). The intervention will be conducted during burn excisional surgery. First, the participant with be anesthetized, whereafter the study medication is administered.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NT
        • Not yet recruiting
        • Martini Hospital
        • Contact:
    • Noord-Holland
      • Beverwijk, Noord-Holland, Netherlands, 1940 EB
        • Not yet recruiting
        • Red Cross Hospital
        • Contact:
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3079 DZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients scheduled for burn excisional surgery
  • An expected blood loss of ≥250ml based on the estimation by the performing surgeon on the basis of: (1) ≥ 2 % body surface area excision planned (100-200 cc / % total body surface area, (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing)
  • ≥18 year
  • informed consent of patient or legal representative
  • Patients or legal representative should have enough knowledge of Dutch to provide informed consent

Exclusion Criteria:

  • Patients with a recorded coagulopathy in their history
  • The use of anticoagulants (except acetylsalicylic acid or (intensive) prophylaxis low molecular weight heparin >12 hours before surgery)
  • Severe kidney failure (creatinine >500 μmol/L)
  • Allergy for tranexamic acid
  • Diagnosis of acute venous-/arterial thrombosis within 3 months before inclusion
  • Diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score >5)
  • Pregnancy
  • Active breastfeeding
  • History of epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tranexamic acid arm

Tranexamic acid 1500 mg dissolved in 100 ml sodium chloride, once, directly after anesthetizing the participant.

In participants with renal insufficiency (creatinine >120 umol/L) the dose will be reduced to 1000 mg.
Drug: Tranexamic acid
Tranexamic acid 1500 mg
Placebo Comparator: Placebo arm
100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.
Drug: Placebo
Placebo, sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: During burn excisional surgery
Volume of blood loss measured during surgery.
During burn excisional surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Mortality
Time Frame: During total admittance of the patient
% of mortality in patients participating in this study.
During total admittance of the patient
Length of stay in days
Time Frame: The length of stay will be evaluated after 3 months after inclusion. If, after 3 months, the patient is still admitted, the status of hospitalisation will be check after an addition 3 months.
Number of days admitted after burn trauma.
The length of stay will be evaluated after 3 months after inclusion. If, after 3 months, the patient is still admitted, the status of hospitalisation will be check after an addition 3 months.
Graft failure in % of total graft
Time Frame: During burn excisional surgery
% of graft failure of the total graft.
During burn excisional surgery
Cardiopulmonary complications
Time Frame: Within the first 30 days after burn excisional surgery
i.e. pulmonary embolism, arterial embolism.
Within the first 30 days after burn excisional surgery
Neurologic complications
Time Frame: Within the first 30 days after burn excisional surgery
i.e. stroke of epilepsy
Within the first 30 days after burn excisional surgery
The need for escape medication
Time Frame: During burn excisional surgery
Out of protocol administration of tranexamic acid based on massive blood loss.
During burn excisional surgery
Extend of fibrinolysis during burn excisional surgery
Time Frame: During burn excisional surgery
Measured by ROTEM analysis
During burn excisional surgery
Strength of blood clot
Time Frame: During burn excisional surgery
Analysis will be performed using (electron) microscope to investigate: strength, thickness, structure of fibrin, fibrin clot networks and cell disposition within the blood clot.
During burn excisional surgery
Transfusion requirements
Time Frame: Perioperative, within the first day after surgery.
Number of transfusions in the perioperative phase.
Perioperative, within the first day after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maasstad Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Red Cross Hospital Beverwijk
Association of Dutch Burn Centres
Martini Hospital Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL69319.100.20
  • WO 19.102 (Other Grant/Funding Number: Dutch Burn Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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