TXA Study in Major Burn Surgery

• ClinicalTrials.gov Identifier: NCT02753816
• Recruitment Status: Terminated
• First Posted: April 28, 2016
• Last Update Posted: January 7, 2020
• Sponsor: Spectrum Health Hospitals
• Information provided by (Responsible Party): Spectrum Health Hospitals

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 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
• Actual Primary Completion Date: December 3, 2019
• Actual Study Completion Date: December 3, 2019

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Michigan

Spectrum Health Hospital

Grand Rapids, Michigan, United States, 49503

Sponsors and Collaborators

Spectrum Health Hospitals

Investigators

• Principal Investigator: Elizabeth Steensma, MD; Spectrum Health Hospitals

More Information

Publications:

Engrav LH, Heimbach DM, Reus JL, Harnar TJ, Marvin JA. Early excision and grafting vs. nonoperative treatment of burns of indeterminant depth: a randomized prospective study. J Trauma. 1983 Nov;23(11):1001-4.

Ong YS, Samuel M, Song C. Meta-analysis of early excision of burns. Burns. 2006 Mar;32(2):145-50. Epub 2006 Jan 18. Review.

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.

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. Review.

Muller M, Gahankari D, Herndon DN. Operative wound management. Total burn care. 2007;3:177-195.

Vermylen J, Verhaegen-Declercq ML, Fierens F, Verstraete M. A double blind study of the effect of tranexamic acid in essential menorrhagia. Bull Soc R Belge Gynecol Obstet. 1968;38(5):385-90.

Prentice CR. Basis of antifibrinolytic therapy. J Clin Pathol Suppl (R Coll Pathol). 1980;14:35-40. Review.

Wei W, Wei B. Comparison of topical and intravenous tranexamic acid on blood loss and transfusion rates in total hip arthroplasty. J Arthroplasty. 2014 Nov;29(11):2113-6. doi: 10.1016/j.arth.2014.07.019. Epub 2014 Jul 30.

Patatanian E, Fugate SE. Hemostatic mouthwashes in anticoagulated patients undergoing dental extraction. Ann Pharmacother. 2006 Dec;40(12):2205-10. Epub 2006 Nov 7. Review.

Mangano DT, Tudor IC, Dietzel C; Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006 Jan 26;354(4):353-65.

Williams-Johnson JA, McDonald AH, Strachan GG, Williams EW. 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. West Indian Med J. 2010 Dec;59(6):612-24.

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.

Tang YM, Chapman TW, Brooks P. Use of tranexamic acid to reduce bleeding in burns surgery. J Plast Reconstr Aesthet Surg. 2012 May;65(5):684-6. doi: 10.1016/j.bjps.2011.09.028. Epub 2011 Oct 7.

Poeran J, Rasul R, Suzuki S, Danninger T, Mazumdar M, Opperer M, Boettner F, Memtsoudis SG. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ. 2014 Aug 12;349:g4829. doi: 10.1136/bmj.g4829.

Satahoo SS, Parikh PP, Naranjo D, Davis JS, Duncan RC, Pizano LR, Namias N, Schulman CI. Are burn patients really at risk for thrombotic events? J Burn Care Res. 2015 Jan-Feb;36(1):100-4. doi: 10.1097/BCR.0000000000000093.

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.

• Responsible Party: Spectrum Health Hospitals
• ClinicalTrials.gov Identifier: NCT02753816
• Other Study ID Numbers: 2015-154
• First Posted: April 28, 2016
• Last Update Posted: January 7, 2020
• Last Verified: January 2020

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:

Burns; Wounds and Injuries; Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants