Tranexamic AcidNCT02753816

TXA Study in Major Burn Surgery

A study testing Tranexamic Acid in people with Tranexamic Acid and Burn, run by Corewell Health West at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Tranexamic Acid, Burn, Major Surgery
What is being tested?: Tranexamic Acid
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Apr 2016to 3 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 (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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Spectrum Health Hospital
Grand Rapids, Michigan, 49503

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Tranexamic Acid, Burn, Major Surgery
Being tested: Tranexamic Acid, Placebo Comparator
Keywords: Tranexamic Acid, Burn, Surgery, Tangential, Excision
Medical subject headings: Burns

What participants receive

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

Tranexamic AcidDrug
Placebo ComparatorDrug

Study groups in NCT02753816
Study group	Role	What they receive
Tranexamic Acid	Experimental	1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Receives: Drug: Tranexamic Acid
Placebo	Placebo comparator	Placebo given over 10 minutes into the vein once prior to surgery Receives: Drug: Placebo Comparator

What is being measured

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

Intraoperative Blood Loss in mL
To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries.
Measured: 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.
Measured: 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
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.
Measured: Hospital admission to hospital discharge

Timeline

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

Apr 20163 Dec 2019

First posted28 Apr 2016 (estimated)
Study startApr 2016
Primary completion3 Dec 2019
Study completion3 Dec 2019

Why it stopped: Study enrollment and goals unable to be reached.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Tranexamic AcidStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02753816
Sponsor's protocol ID: 2015-154
Status last verified: Apr 2021
First submitted: 18 Apr 2016
Last updated: 23 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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. doi: 10.1097/00005373-198311000-00007.
PubMed 6355500
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.
PubMed 16414197
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
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. No abstract available.
PubMed 4890296
Prentice CR. Basis of antifibrinolytic therapy. J Clin Pathol Suppl (R Coll Pathol). 1980;14:35-40. No abstract available.
PubMed 6159375
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.
PubMed 25155138
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.
PubMed 17090725
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.
PubMed 16436767
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.
PubMed 21702233
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.
PubMed 21983540
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.
PubMed 25116268
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.
PubMed 25084492

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
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Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
Not yet recruitingPhase 4
Oral Tranexamic Acid After Total Knee Arthroplasty
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Not yet recruitingPhase 2
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement.
Ankle Arthritis, Wound Complication

All Tranexamic Acid trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02753816
Acronym / sponsor ID: 2015-154
Conditions: Tranexamic Acid, Burn, Major Surgery
Keywords: Tranexamic Acid, Burn, Surgery, Tangential, Excision
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study enrollment and goals unable to be reached.
Enrolment: 25 participants (actual)
Lead sponsor: Corewell Health WestUniversity, hospital or other
Study start: Apr 2016
Primary completion: 3 Dec 2019 (actual)
Study completion: 3 Dec 2019 (actual)
First posted: 28 Apr 2016 (estimated)
Results: Posted 23 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tranexamic Acid	Experimental	Drug: Tranexamic Acid1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery
Placebo	Placebo comparator	Drug: Placebo ComparatorPlacebo given over 10 minutes into the vein once prior to surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tranexamic Acid	Drug	Tranexamic Acid
Placebo Comparator	Drug	Placebo

Primary outcome

Intraoperative Blood Loss in mL
Time frame: Intraoperative, average 122 minutes
To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries.
Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion
Time frame: First burn surgery to hospital discharge
To determine the impact of perioperative administration of Tranexamic Acid on transfusion rates in major burn surgeries.

1 secondary outcome

Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury
Time frame: Hospital admission to hospital discharge

Results and safety

Results posted to the registry on 23 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tranexamic Acid	7	7
Placebo	11	10
Tranexamic Acid and Placebo	7	7

Primary outcome: Intraoperative Blood Loss in mL

Time frame: Intraoperative, average 122 minutes. Median (Inter-Quartile Range). Unit: mL

Measure	Tranexamic Acid n = 14	Placebo n = 15
Value	100 (100 to 200)	325 (200 to 500)

Population analysed: 1 patient in the Placebo group was excluded from this analysis. Patient was randomized to treatment but never received the treatment intraoperatively. 1 additional patient from the Placebo group was also excluded due to the missing data required to calculate intraoperative blood loss.

Primary outcome: Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion

Time frame: First burn surgery to hospital discharge. Number. Unit: Patients with 1 or more transfusions

Measure	Tranexamic Acid n = 13	Placebo n = 15
Value	2	3

Population analysed: 1 patient in the Placebo group was excluded from this analysis. Patient was randomized to treatment but never received the treatment intraoperatively. 1 additional patient from the Placebo group was also excluded due the missing data required to calculate transfusion rate . 1 patient from the Tranexamic Acid group was excluded due to missing data required to calculate transfusion rate.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Hospital admission to hospital discharge. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tranexamic Acid	2 of 14 (14.3%)	0 of 14 (0%)	1 of 14
Placebo	1 of 17 (5.9%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 6355500Engrav 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.
Background: PubMed 16414197Ong 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.
Background: PubMed 2357138Desai 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.
Background: PubMed 21367529Curinga 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.
BackgroundMuller M, Gahankari D, Herndon DN. Operative wound management. Total burn care. 2007;3:177-195.
Background: PubMed 4890296Vermylen 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.
Background: PubMed 6159375Prentice CR. Basis of antifibrinolytic therapy. J Clin Pathol Suppl (R Coll Pathol). 1980;14:35-40. No abstract available.
Background: PubMed 25155138Wei 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.
Background: PubMed 17090725Patatanian 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.
Background: PubMed 16436767Mangano 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.
Background: PubMed 21702233Williams-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.
BackgroundJennes 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.
Individual participant dataSharing planned: No

Related trials for Tranexamic Acid

Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
Melasma (Facial Melasma)
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
Not yet recruitingPhase 4
Oral Tranexamic Acid After Total Knee Arthroplasty
Total Knee Arthroplasty
Not yet recruitingPhase 2
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement.
Ankle Arthritis, Wound Complication

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth Steensma, MD principal investigator

Corewell Health West

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tranexamic Acid in people with Tranexamic Acid and Burn, run by Corewell Health West at 1 site in United States.

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 8 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: stopped early, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intraoperative Blood Loss in mL (time frame: Intraoperative, average 122 minutes). The study lists 2 primary outcomes in all. 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 NCT02753816, which also lists 17 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 23 Aug 2021.