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Tranexamic AcidPhase 4TRANBURNNCT03113253

TRANexamic Acid to Reduce Bleeding in BURN Surgery

A Phase 4 study testing Tranexamic Acid in people with Tranexamic Acid and Burns, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 4 sites in France.

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

Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in Saint Joseph Saint Luc Hospital showed that the total median blood loss was 1412 mL (1). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tranexamic Acid, Burns, Surgery
What is being tested?
Tranexamic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
4 sitesFrance
Study dates
22 Sep 2016to 13 Nov 2021
Phase
Phase 4
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

  • Subjects undergoing burn excision surgery for standard of care purposes
  • Male or female >= 18 years of age
  • Subject or subject's medical decision maker agrees to participate in this study and provides informed consent

Who cannot join

  • Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism
  • Renal impairment
  • Subjects with known hypersensitivity to tranexamic acid
  • Consecutive fibrinolytic states to coagulopathy
  • History of convulsions

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Service de réanimation des brûlés de Mercy (CHR Metz-Thionville)

    Ars-Laquenexy

  • Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot

    Lyon, 69437

  • Centre Hospitalier Saint Joseph Saint Luc

    Lyon

  • Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception

    Marseille

Other trials in France

About this study

Official title: The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial

Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in Saint Joseph Saint Luc Hospital showed that the total median blood loss was 1412 mL (1). Transfused patients had a total median blood loss of 2468 mL and an average number of 4 packed red blood cells (PRBC) administered.

Among the various methods that help limit blood loss, tranexamic acid, which has been proved useful in traumatology and surgery, has not been sufficiently studied in burn patients. A preliminary study in 27 burned patients showed a reduction of blood loss with tranexamic acid (2).

Objective of TRANBURN study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.

Read the detailed description

The first aim of the study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.

Secondary objectives are to evaluate impact of tranexamic acid on mortality, success of skin grafts and occurrence of deep vein thrombosis or myocardial infarction.

Being tested
Tranexamic Acid, Placebo
Keywords
Tranexamic Acid, Burn, Surgery, Excision
Medical subject headings
Burns, Wounds and Injuries

What participants receive

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

  • Tranexamic AcidDrug

    Also called Exacyl

  • PlaceboDrug

    Also called 0.9% sodium chloride

    0.9% sodium chloride to mimic tranexamic acid

Study groups in NCT03113253
Study groupRoleWhat they receive
Tranexamic AcidExperimentalPatient will receive: * 1g of tranexamic acid by slow intravenous injection * 1g of tranexamic acid by syringe pump during 8 hours
Receives: Drug: Tranexamic Acid
PlaceboPlacebo comparatorPatient will receive: * 10 mL of 0.9% sodium chloride by slow intravenous injection * 48 mL of 0.9% sodium chloride by syringe pump during 8 hours
Receives: Drug: Placebo

What is being measured

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

  1. Blood loss (mL / cm² excised)

    To determine the impact of tranexamic acid on blood loss in burn surgeries

    Measured: Until day 5 post surgery

Secondary outcomes (8)

  1. Need for transfusion

    Number of blood product transfused

    Measured: Until day 5 post surgery

  2. All-cause Hospital Mortality

    Any death during hospital stay

    Measured: Until day 15 post surgery

  3. Success of skin graft

    Number of successful skin graft (medical assessment)

    Measured: Until day 15 post surgery

  4. Deep vein thrombosis

    Number of deep vein thrombosis

    Measured: Until day 15 post surgery

  5. Myocardial infarction

    Number of myocardial infarctions

    Measured: Until day 15 post surgery

  6. Stroke

    Number of strokes

    Measured: Until day 15 post surgery

  7. Pulmonary embolism

    Number of pulmonary embolisms

    Measured: Until day 15 post surgery

  8. Convulsion

    Number of convulsions

    Measured: Until day 15 post surgery

Timeline

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

  1. First posted13 Apr 2017
  2. Study start22 Sep 2016
  3. Primary completion2 Nov 2021
  4. Study completion13 Nov 2021

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03113253
Sponsor's protocol ID
TRANBURN
Acronym
TRANBURN
Status last verified
Apr 2024
First submitted
10 Apr 2017
Last updated
4 Apr 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Farny B, Fontaine M, Payre J, Ravat F, Poupelin J-C, Latarjet J. Évaluation des pertes sanguines lors des chirurgies d'excision-autogreffe de peau chez les patients brûlés. Anesthésie & Réanimation. 2015;1:A307-8.

  • Jennes S, Degrave E, Despiegeleer X, Grenez O. Effect of Tranexamic Acid on Blood Loss in Burn Surgery: A Preliminary Study. Journal of Burn Care & Rehabilitation. 2003;24:S59.

  • Mercuriali F, Inghilleri G. Proposal of an algorithm to help the choice of the best transfusion strategy. Curr Med Res Opin. 1996;13(8):465-78. doi: 10.1185/03007999609115227.

    PubMed 9010613

  • Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.

    PubMed 22611164

  • Zufferey P, Merquiol F, Laporte S, Decousus H, Mismetti P, Auboyer C, Samama CM, Molliex S. Do antifibrinolytics reduce allogeneic blood transfusion in orthopedic surgery? Anesthesiology. 2006 Nov;105(5):1034-46. doi: 10.1097/00000542-200611000-00026.

    PubMed 17065899

  • CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

    PubMed 20554319

  • Desai MH, Herndon DN, Broemeling L, Barrow RE, Nichols RJ Jr, Rutan RL. Early burn wound excision significantly reduces blood loss. Ann Surg. 1990 Jun;211(6):753-9; discussion 759-62. doi: 10.1097/00000658-199006000-00015.

    PubMed 2357138

  • Curinga G, Jain A, Feldman M, Prosciak M, Phillips B, Milner S. Red blood cell transfusion following burn. Burns. 2011 Aug;37(5):742-52. doi: 10.1016/j.burns.2011.01.016. Epub 2011 Mar 1.

    PubMed 21367529

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic Acid in people with Tranexamic Acid and Burns, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 4 sites in France.

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 3 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Blood loss (mL / cm² excised) (time frame: Until day 5 post surgery). 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 NCT03113253, which also lists 8 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 4 Apr 2024.

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