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Trial record 2 of 419 for:    TRANEXAMIC ACID

TRANexamic Acid to Reduce Bleeding in BURN Surgery (TRANBURN)

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ClinicalTrials.gov Identifier: NCT03113253
Recruitment Status : Unknown
Verified April 2017 by Centre Hospitalier Saint Joseph Saint Luc de Lyon.
Recruitment status was:  Recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Société Française d'Anesthésie et de Réanimation
Information provided by (Responsible Party):
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Brief Summary:

Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in our burn unit 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.


Condition or disease Intervention/treatment Phase
Tranexamic Acid Burns Surgery Wounds and Injuries Drug: Tranexamic Acid Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial
Actual Study Start Date : September 22, 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Burns

Arm Intervention/treatment
Experimental: Tranexamic Acid

Patient will receive:

  • 1g of tranexamic acid by slow intravenous injection
  • 1g of tranexamic acid by syringe pump during 8 hours
Drug: Tranexamic Acid
Other Name: Exacyl

Placebo Comparator: Placebo

Patient 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
Drug: Placebo
0.9% sodium chloride to mimic tranexamic acid
Other Name: 0.9% sodium chloride




Primary Outcome Measures :
  1. Blood loss (mL / cm² excised) [ Time Frame: Until day 5 post surgery ]
    To determine the impact of tranexamic acid on blood loss in burn surgeries


Secondary Outcome Measures :
  1. Need for transfusion [ Time Frame: Until day 5 post surgery ]
    Number of blood product transfused

  2. All-cause Hospital Mortality [ Time Frame: Until day 15 post surgery ]
    Any death during hospital stay

  3. Success of skin graft [ Time Frame: Until day 15 post surgery ]
    Number of successful skin graft

  4. Deep vein thrombosis [ Time Frame: Until day 15 post surgery ]
    Number of deep vein thrombosis

  5. Myocardial infarction [ Time Frame: Until day 15 post surgery ]
    Number of myocardial infarctions

  6. Stroke [ Time Frame: Until day 15 post surgery ]
  7. Pulmonary embolism [ Time Frame: Until day 15 post surgery ]
  8. Convulsion [ Time Frame: Until day 15 post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113253


Contacts
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Contact: Mathieu Fontaine +33478618945 brules@ch-stjoseph-stluc-lyon.fr

Locations
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France
Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot Not yet recruiting
Lyon, France, 69437
Contact: Thomas Rimmelé, MD, PhD    +33472116988    thomas.rimmele@chu-lyon.fr   
Centre Hospitalier Saint Joseph Saint Luc Recruiting
Lyon, France
Contact: Stéphane Rio    +33478618216    srio@ch-stjoseph-stluc-lyon.fr   
Principal Investigator: Mathieu Fontaine, MD, PhD         
Sub-Investigator: François Ravat, MD         
Sub-Investigator: Jacques Latarjet, MD         
Sub-Investigator: Delphine Voulliaume, MD         
Sub-Investigator: Jacqueline Payre, MD         
Sub-Investigator: Jean-Charles Poupelin, MD         
Sponsors and Collaborators
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Société Française d'Anesthésie et de Réanimation
Investigators
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Principal Investigator: Mathieu Fontaine, MD, PhD Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit

Additional Information:
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.

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Responsible Party: Centre Hospitalier Saint Joseph Saint Luc de Lyon
ClinicalTrials.gov Identifier: NCT03113253     History of Changes
Other Study ID Numbers: 2016-06
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Saint Joseph Saint Luc de Lyon:
Tranexamic Acid
Burn
Surgery
Excision
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants