Burn, Major Surgery, Tranexamic Acid
Conditions
Keywords
Tranexamic Acid, Burn, Surgery, Tangential, Excision
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.
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.
Interventions
DRUGTranexamic Acid
DRUGPlacebo Comparator
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Blood Loss in mL | 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 | First burn surgery to hospital discharge | To determine the impact of perioperative administration of Tranexamic Acid on transfusion rates in major burn surgeries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury | Hospital admission to 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery
Tranexamic Acid | 7 |
| Placebo Placebo given over 10 minutes into the vein once prior to surgery
Placebo Comparator | 11 |
| Tranexamic Acid and Placebo (see participant flow) | 7 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Tranexamic Acid | Placebo | Tranexamic Acid and Placebo |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 3 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 7 Participants | 8 Participants | 6 Participants |
| Age, Continuous | 47.6 years | 37.2 years | 53.7 years | 48.6 years |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment United States | 25 Participants | 7 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Female | 7 Participants | 1 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Male | 18 Participants | 6 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 14 | 0 / 17 |
| other Total, other adverse events | 0 / 14 | 0 / 17 |
| serious Total, serious adverse events | 2 / 14 | 1 / 17 |
Outcome results
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.
Time frame: First burn surgery to hospital discharge
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tranexamic Acid | Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion | 2 Patients with 1 or more transfusions |
| Placebo | Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion | 3 Patients with 1 or more transfusions |
Primary
Intraoperative Blood Loss in mL
To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries.
Time frame: Intraoperative, average 122 minutes
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Intraoperative Blood Loss in mL | 100 mL |
| Placebo | Intraoperative Blood Loss in mL | 325 mL |
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.
Time frame: Hospital admission to hospital discharge
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury | 23 Days |
| Placebo | Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury | 9 Days |