NCT02753816

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 23, 2021

Completed
Last Updated

August 23, 2021

Status Verified

April 1, 2021

Enrollment Period

3.7 years

First QC Date

April 18, 2016

Results QC Date

April 23, 2021

Last Update Submit

August 20, 2021

Conditions

Tranexamic AcidBurnMajor Surgery

Keywords

Tranexamic AcidBurnSurgeryTangentialExcision

Outcome Measures

Primary Outcomes (2)

  • Intraoperative Blood Loss in mL

    To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries.

    Intraoperative, average 122 minutes

  • Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion

    To determine the impact of perioperative administration of Tranexamic Acid on transfusion rates in major burn surgeries.

    First burn surgery to hospital discharge

Secondary Outcomes (1)

  • Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury

    Hospital admission to hospital discharge

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Placebo given over 10 minutes into the vein once prior to surgery

Drug: Placebo Comparator

Interventions

Tranexamic AcidDRUG
Tranexamic Acid
Placebo ComparatorDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spectrum Health Hospital

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (17)

  • 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. doi: 10.1097/00005373-198311000-00007.

    PMID: 6355500BACKGROUND

  • Ong YS, Samuel M, Song C. Meta-analysis of early excision of burns. Burns. 2006 Mar;32(2):145-50. doi: 10.1016/j.burns.2005.09.005. Epub 2006 Jan 18.

    PMID: 16414197BACKGROUND

  • 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.

    PMID: 2357138BACKGROUND

  • 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.

    PMID: 21367529BACKGROUND

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

    BACKGROUND

  • 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. No abstract available.

    PMID: 4890296BACKGROUND

  • Prentice CR. Basis of antifibrinolytic therapy. J Clin Pathol Suppl (R Coll Pathol). 1980;14:35-40. No abstract available.

    PMID: 6159375BACKGROUND

  • 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.

    PMID: 25155138BACKGROUND

  • Patatanian E, Fugate SE. Hemostatic mouthwashes in anticoagulated patients undergoing dental extraction. Ann Pharmacother. 2006 Dec;40(12):2205-10. doi: 10.1345/aph.1H295. Epub 2006 Nov 7.

    PMID: 17090725BACKGROUND

  • 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. doi: 10.1056/NEJMoa051379.

    PMID: 16436767BACKGROUND

  • 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.

    PMID: 21702233BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 21983540BACKGROUND

  • 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.

    PMID: 25116268BACKGROUND

  • 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.

    PMID: 25084492BACKGROUND

  • Twisk JWR. Applied Multilevel Analysis: A Practical Guide for Medical Researchers. 2006. Cambridge University Press, London, UK.

    BACKGROUND

  • American Burn Association. Burn incidence fact sheet. http://www.ameriburn.org/resources_factsheet.php. Accessed May 20, 2015.

    BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Dr. Betsy Steensma
Organization
Spectrum Health
elizabeth.steensma@spectrumhealth.org
(616) 391-5701

Study Officials

  • Elizabeth Steensma, MD

    Corewell Health West

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 28, 2016

Study Start

April 1, 2016

Primary Completion

December 3, 2019

Study Completion

December 3, 2019

Last Updated

August 23, 2021

Results First Posted

August 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)