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Study enrollment and goals unable to be reached.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery |
|
| Placebo | Placebo Comparator | Placebo given over 10 minutes into the vein once prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
| ||
| Placebo Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Steensma, MD | Corewell Health West | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health Hospital | Grand Rapids | Michigan | 49503 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6355500 | Background | 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. | |
| 16414197 | Background | 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. |
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Enrolled participants can have multiple surgeries during the course of their stay. This is the reason for the discrepancy between the protocol enrollment and the participant flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid | 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid |
| FG001 | Placebo | Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator |
| FG002 | Tranexamic Acid and Placebo | Patients whom received Tranexamic Acid during one surgery and Placebo in another surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid | 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid |
| BG001 | Placebo | Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative Blood Loss in mL | To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries. | 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. | Posted | Median | Inter-Quartile Range | mL | Intraoperative, average 122 minutes |
|
Hospital admission to hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid | 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NSTEMI | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | suffered MI (Myocardial Infarction) one day following treatment - MI was determined to be "Severe, Not at all related" |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Betsy Steensma | Spectrum Health | (616) 391-5701 | elizabeth.steensma@spectrumhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2018 | Apr 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Hospital admission to hospital discharge |
| 2357138 | Background | 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. |
| 21367529 | Background | 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. |
| Background | Muller M, Gahankari D, Herndon DN. Operative wound management. Total burn care. 2007;3:177-195. |
| 4890296 | 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. |
| 6159375 | Background | Prentice CR. Basis of antifibrinolytic therapy. J Clin Pathol Suppl (R Coll Pathol). 1980;14:35-40. No abstract available. |
| 25155138 | Background | 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. |
| 17090725 | Background | 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. |
| 16436767 | Background | 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. |
| 21702233 | Background | 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. |
| Background | 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. |
| 21983540 | 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. |
| 25116268 | Background | 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. |
| 25084492 | Background | 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. |
| Background | 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. |
| BG002 | Tranexamic Acid and Placebo | (see participant flow) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Placebo given over 10 minutes into the vein once prior to surgery
Placebo Comparator
|
|
| Primary | 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. | 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. | Posted | Number | Patients with 1 or more transfusions | First burn surgery to hospital discharge |
|
|
|
| Secondary | 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. | For this analysis we compared patients that only received either Tranexamic Acid or Placebo. 3 patients from the Tranexamic Acid group and 2 from the Placebo group were not included in the analysis due to missing data on their length of stay. | Posted | Median | Inter-Quartile Range | Days | Hospital admission to hospital discharge |
|
|
|
| 1 |
| 14 |
| 2 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo | Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator | 0 | 17 | 1 | 17 | 0 | 17 |
|
| Pulmonary Embolism | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment | Suffered PE (Pulmonary Embolism) 3 days following treatment
|
|
| Acute Myocardial Infarction | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Patient suffered an Acute Myocardial Infarction one day after study procedure |
|
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|