BurnsPhase 3NCT05855590
Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements
A Phase 3 study testing Tranexamic acid and 0.9% isotonic saline solution in people with Burns, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Tranexamic acid in debridement surgery of burns on the volume of bleeding in transfusion requirements Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Burns
- What is being tested?
- Tranexamic acid and 0.9% isotonic saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2022to 30 Dec 2023
- Phase
- Phase 3
- 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 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- First-time patients undergo surgical debridement of their burns.
- A burn percentage of 10-30% of burned body surface area
- Patients over 18 years of age
- Patients under 40
- IMSS beneficiaries
Who cannot join
- Burned patients with previous surgical debridement.
- Patients with co-morbids.
- Patients with a history of drug hypersensitivity.
- Patients with kidney disease.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro Médico Nacional de Occidente
Guadalajara, Jalisco, 44329
Alejandro González Ojeda, PhD, 3336683000, avygail5@gmail.com
Gonzalo Delgado-Hernandez, 3321822949, medicinagon@gmail.com
About this study
Official title: Efficacy of Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements at Centro Medico de Occidente'
Tranexamic acid in debridement surgery of burns on the volume of bleeding in transfusion requirements
Read the detailed description
A randomized, double-blind, prospective trial was conducted to establish the effect of intraoperative tranexamic acid in the early surgical debridement of severe burns. The study was carried out between the months of January 2022 and December 2023.
- Conditions
- Burns
- Being tested
- Tranexamic acid, 0.9% isotonic saline solution
- Keywords
- burns
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
10mg/kg intravenous single dose
0.9% isotonic saline solutionOther
100 ml intravenous single dose
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Experimental | A total of 20 patients were included: 9 patients in the tranexamic acid group Receives: Drug: Tranexamic acid |
| placebo | Placebo comparator | A total of 20 patients were included: 11 patients in the control group using 0.9% isotonic saline solution. Receives: Other: 0.9% isotonic saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the group with tranexamic acid with the group with saline solution.
The differences between the groups at the beginning of the study were evaluated with the Student's t test for continuous variables, and the proportions were compared with the Chi2 or Fisher test.
Measured: The time frame: the total time of the study is during the first day, only one dose will be given, and they will be compared at 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized, double-blind, prospective trial to establish the effect of intraoperative tranexamic acid in early surgical debridement of severe burns. The study was carried out between the months of January 2022 to December 2022.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855590
- Sponsor's protocol ID
- Tranexamic project
- Status last verified
- May 2023
- First submitted
- 30 Mar 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dominguez A, Alsina E, Landin L, Garcia-Miguel JF, Casado C, Gilsanz F. Transfusion requirements in burn patients undergoing primary wound excision: effect of tranexamic acid. Minerva Anestesiol. 2017 Apr;83(4):353-360. doi: 10.23736/S0375-9393.16.10992-7. Epub 2016 Nov 9.
PubMed 27827518K S A, Kumar P, Subair M, Sharma RK. Effect of single dose intravenous tranexamic acid on blood loss in tangential excision of burn wounds - A double blind randomised controlled trial. Burns. 2022 Sep;48(6):1311-1318. doi: 10.1016/j.burns.2021.08.021. Epub 2021 Aug 30.
PubMed 34952736Brown NJ, Choi EH, Gendreau JL, Ong V, Himstead A, Lien BV, Shahrestani S, Ransom SC, Tran K, Tafreshi AR, Sahyouni R, Chan A, Oh MY. Association of tranexamic acid with decreased blood loss in patients undergoing laminectomy and fusion with posterior instrumentation: a systematic review and meta-analysis. J Neurosurg Spine. 2021 Nov 5;36(4):686-693. doi: 10.3171/2021.7.SPINE202217. Print 2022 Apr 1.
PubMed 34740174Tapking C, Hundeshagen G, Kirchner M, Fischer S, Kneser U, Bliesener B. Tranexamic acid reduced blood transfusions in acute burn surgery: A retrospective case-controlled trial. Burns. 2022 May;48(3):522-528. doi: 10.1016/j.burns.2022.03.002. Epub 2022 Mar 16.
PubMed 35339324Castillo-Cardiel G, Avalos-Lopez M, Mendez-Miranda C, Gil-Vigna JA, Fuentes-Orozco C, Cervantes-Guevara G, Cervantes-Perez E, Ramirez-Ochoa S, Alvarez-Villasenor AS, Cortes-Flores AO, Morfin-Meza KD, Garcia A, Vazquez-Sanchez SJ, Gonzalez-Ojeda A. Comparative efficacy of tranexamic acid versus placebo on hemostatic outcomes after the surgical debridement of burn patients: A randomized controlled clinical trial. Burns. 2025 Mar;51(2):107339. doi: 10.1016/j.burns.2024.107339. Epub 2024 Nov 30.
PubMed 39721243
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements at Centro Medico de Occidente'
- ClinicalTrials.gov ID
- NCT05855590
- Acronym / sponsor ID
- Tranexamic project
- Conditions
- Burns
- Keywords
- burns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tranexamic acid in debridement surgery of burns on the volume of bleeding in transfusion requirements
Detailed description
A randomized, double-blind, prospective trial was conducted to establish the effect of intraoperative tranexamic acid in the early surgical debridement of severe burns. The study was carried out between the months of January 2022 and December 2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, prospective trial to establish the effect of intraoperative tranexamic acid in early surgical debridement of severe burns. The study was carried out between the months of January 2022 to December 2022.
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Experimental | Drug: Tranexamic acidA total of 20 patients were included: 9 patients in the tranexamic acid group |
| placebo | Placebo comparator | Other: 0.9% isotonic saline solutionA total of 20 patients were included: 11 patients in the control group using 0.9% isotonic saline solution. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- First-time patients undergo surgical debridement of their burns.
- A burn percentage of 10-30% of burned body surface area
- Patients over 18 years of age
- Patients under 40
- IMSS beneficiaries
Key exclusion criteria (4 listed)
- Burned patients with previous surgical debridement.
- Patients with co-morbids.
- Patients with a history of drug hypersensitivity.
- Patients with kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid10mg/kg intravenous single dose | Drug | tranexamic acid |
| 0.9% isotonic saline solution100 ml intravenous single dose | Other | placebo |
Primary outcome
Compare the group with tranexamic acid with the group with saline solution.
Time frame: The time frame: the total time of the study is during the first day, only one dose will be given, and they will be compared at 24 hours.
The differences between the groups at the beginning of the study were evaluated with the Student's t test for continuous variables, and the proportions were compared with the Chi2 or Fisher test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 27827518Dominguez A, Alsina E, Landin L, Garcia-Miguel JF, Casado C, Gilsanz F. Transfusion requirements in burn patients undergoing primary wound excision: effect of tranexamic acid. Minerva Anestesiol. 2017 Apr;83(4):353-360. doi: 10.23736/S0375-9393.16.10992-7. Epub 2016 Nov 9.
- Background: PubMed 34952736K S A, Kumar P, Subair M, Sharma RK. Effect of single dose intravenous tranexamic acid on blood loss in tangential excision of burn wounds - A double blind randomised controlled trial. Burns. 2022 Sep;48(6):1311-1318. doi: 10.1016/j.burns.2021.08.021. Epub 2021 Aug 30.
- Background: PubMed 34740174Brown NJ, Choi EH, Gendreau JL, Ong V, Himstead A, Lien BV, Shahrestani S, Ransom SC, Tran K, Tafreshi AR, Sahyouni R, Chan A, Oh MY. Association of tranexamic acid with decreased blood loss in patients undergoing laminectomy and fusion with posterior instrumentation: a systematic review and meta-analysis. J Neurosurg Spine. 2021 Nov 5;36(4):686-693. doi: 10.3171/2021.7.SPINE202217. Print 2022 Apr 1.
- Results publication: PubMed 35339324Tapking C, Hundeshagen G, Kirchner M, Fischer S, Kneser U, Bliesener B. Tranexamic acid reduced blood transfusions in acute burn surgery: A retrospective case-controlled trial. Burns. 2022 May;48(3):522-528. doi: 10.1016/j.burns.2022.03.002. Epub 2022 Mar 16.
- Derived from this study: PubMed 39721243Castillo-Cardiel G, Avalos-Lopez M, Mendez-Miranda C, Gil-Vigna JA, Fuentes-Orozco C, Cervantes-Guevara G, Cervantes-Perez E, Ramirez-Ochoa S, Alvarez-Villasenor AS, Cortes-Flores AO, Morfin-Meza KD, Garcia A, Vazquez-Sanchez SJ, Gonzalez-Ojeda A. Comparative efficacy of tranexamic acid versus placebo on hemostatic outcomes after the surgical debridement of burn patients: A randomized controlled clinical trial. Burns. 2025 Mar;51(2):107339. doi: 10.1016/j.burns.2024.107339. Epub 2024 Nov 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid and 0.9% isotonic saline solution in people with Burns, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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 Mexico. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Gonzalez-Ojeda, PhD (33 312 941 65 ext. 52, avygail5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the group with tranexamic acid with the group with saline solution. (time frame: The time frame: the total time of the study is during the first day, only one dose will be given, and they will be compared at 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 NCT05855590, which also lists 5 linked publications.
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 11 May 2023.