TXA Study in Major Burn Surgery
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| ClinicalTrials.gov Identifier: NCT02753816 |
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Recruitment Status :
Recruiting
First Posted : April 28, 2016
Last Update Posted : June 11, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tranexamic Acid Burn Major Surgery | Drug: Tranexamic Acid Drug: Placebo Comparator | Not Applicable |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Tranexamic Acid
1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery
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Drug: Tranexamic Acid |
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Placebo Comparator: Placebo
Placebo given over 10 minutes into the vein once prior to surgery
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Drug: Placebo Comparator |
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: Steffen Pounders, BS | 616.486.0461 | Steffen.Pounders@spectrumhealth.org | |
| Contact: Mona Wojtas, BS | 616.486.2054 |
| 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 | |
| Principal Investigator: | Elizabeth Steensma, MD | Spectrum Health Hospitals |
Publications:
| 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:
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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 |