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Trial record 1 of 3 for:    TXA Burn
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TXA Study in Major Burn Surgery

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ClinicalTrials.gov Identifier: NCT02753816
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Spectrum Health Hospitals

Brief Summary:

Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid (TXA) is a medication that was first introduced in the 1960's as a treatment for heavy menstrual bleeding. Over the past 20 years, it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. Investigators believe tranexamic acid may possibly decrease bleeding related to major burn surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your stay.

In this study, prior to each surgical procedure to treat the participants burn injury, the participant will receive either the drug tranexamic acid or placebo. The placebo is a liquid that looks like the tranexamic acid medicine, but does not have any active ingredient in it. In this study, both the tranexamic acid and the placebo are considered research.


Condition or disease Intervention/treatment Phase
Tranexamic Acid Burn Major Surgery Drug: Tranexamic Acid Drug: Placebo Comparator Not Applicable

Detailed Description:

Neither the participant nor the study doctor will choose what treatment the participant gets. The participant will have an equal chance of being given the tranexamic acid or the placebo. Neither the participant nor the study doctor will know which treatment the participant is receiving.

The participant will receive one 1 gram dose of either tranexamic acid or placebo immediately before surgery. The dose of tranexamic acid or placebo will be given in the participants vein over a 10-minute period.

Information from the participants medical record related to their surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with the participants study number instead of their name.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 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 and Transfusion Rates in Burn Wound Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial
Study Start Date : April 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic Acid
1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery
Drug: Tranexamic Acid
Placebo Comparator: Placebo
Placebo given over 10 minutes into the vein once prior to surgery
Drug: Placebo Comparator



Primary Outcome Measures :
  1. Intraoperative Blood Loss as Measured by Pre and Post Procedure Hemoglobin levels (g/dl) [ Time Frame: From time of surgery to 30 days post hospital discharge ]
    To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries.

  2. Post Operative Transfusion Rates as Determined by Hemoglobin Levels of < 7.0 g/dl or <10.0 g/dl with clinical symptomology [ Time Frame: From time of surgery to 30 days post hospital discharge ]
    To determine the impact of perioperative administration of Tranexamic Acid on transfusion rates in major burn surgeries.


Secondary Outcome Measures :
  1. Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury [ Time Frame: From time of surgery to 30 days post hospital discharge ]
    To determine the impact of Tranexamic Acid on total hospital length of stay by comparing the hospital admission date and the hospital discharge date. This determination will take into account current burn size and location, procedures performed and their effect on wound healing and skin graft survival.



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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 (to include: greater than or equal to 350 cm2 of full thickness or deep partial thickness burns)
  • 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
  • Baseline creatinine level greater than 2.83 mg/dL
  • Subjects with known hypersensitivity to tranexamic acid
  • Patients with acquired defective color vision
  • Patients with subarachnoid hemorrhage
  • Children
  • Pregnant women
  • Prisoners

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): NCT02753816


Contacts
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Contact: Steffen Pounders, BS 616.486.0461 Steffen.Pounders@spectrumhealth.org
Contact: Mona Wojtas, BS 616.486.2054

Locations
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United States, Michigan
Spectrum Health Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Steffen Pounders, BS    616-486-0461    Steffen.Pounders@spectrumhealth.org   
Contact: Mona Wojtas, BS    616.486.2054    Mona.Wojtas@spectrumhealth.org   
Sub-Investigator: Richard Wilcox, MD         
Sub-Investigator: Nicholas Adams, MD         
Sub-Investigator: Wendy Thomas, PharmD         
Sub-Investigator: Alistair Chapman, MD         
Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
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Principal Investigator: Elizabeth Steensma, MD Spectrum Health Hospitals

Publications:
Muller M, Gahankari D, Herndon DN. Operative wound management. Total burn care. 2007;3:177-195.
Jennes S, Degrave E, Despiegeleer X, Grenez O. Effect of tranexamic acid on blood loss in burn surgery: A preliminary study: 33. Journal of Burn Care & Research. 2003;24:S59.
Twisk JWR. Applied Multilevel Analysis: A Practical Guide for Medical Researchers. 2006. Cambridge University Press, London, UK.
American Burn Association. Burn incidence fact sheet. http://www.ameriburn.org/resources_factsheet.php. Accessed May 20, 2015.

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Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02753816     History of Changes
Other Study ID Numbers: 2015-154
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Spectrum Health Hospitals:
Tranexamic Acid
Burn
Surgery
Tangential
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