Curvature of Spine
Conditions
Brief summary
The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.
Detailed description
There are conflicting studies in the literature reporting different efficacy outcomes for the use of antifibrinolytics in spine fusion surgery. Several studies support the successful use of tranexamic acid for major orthopedic procedures, but the patient populations studied for spine surgery thus far have been small and highly variable, with less than clinically significant results. If TXA if efficacious in reducing not only perioperative blood loss, but RBC transfusion without an increase in thromboembolic events, then its use may be justified for patients at risk for major blood transfusion.
Interventions
DRUGTranexamic Acid
intravenous administration of bolus and infusion for duration of surgical procedure
Sponsors
Northwestern University
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
* age\>17 years * undergoing posterior spine fusion surgery for kyphoscoliosis with a \>80% chance of major transfusion
Exclusion criteria
* age \< 18 years * non-English speaking * pregnancy * emergency procedures * surgery for tumor, trauma or infection * severe coronary artery disease * history of venous thromboembolism * history of cerebral vascular accident * history of renal insufficiency * allergy to tranexamic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Red Blood Cells Transfused in the Intraoperative Period | Intraoperative period (approximately 12 hours) | Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Blood Products Transfused | 24 hours after skin incision | Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units. |
| Post Operative Major Morbidity | Time of surgery to date of discharge from hospital (average 7 days) | Number of participants who experienced arterial or venous thromboembolism, neurologic complications (including stroke, seizure,and delirium), infections, and pulmonary renal or cardiac adverse outcomes (demand ischemia, myocardial infarction or new arrhythmia) before another operative procedure or hospital discharge. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Estimated Intraoperative Blood Loss | Incision to skin closure (approximately 10 hours) | Estimated Intraoperative blood loss in milliliters (mLs) |
| Total Tranexamic Acid Dose (mg) | Intraoperative period | Total milligrams of intravenous tranexamic acid administered during the surgical procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period
Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure | 31 |
| Placebo Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course
Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure | 30 |
| Total | 61 |
Baseline characteristics
| Characteristic | Total | Tranexamic Acid | Placebo |
|---|---|---|---|
| Age, Continuous | 66 Years | 68 Years | 65 Years |
| ASA status | 2 score on a scale | 2 score on a scale | 2 score on a scale |
| Baseline fibrinogen (mg/dL) | 270 miligrams per deciliter | 272 miligrams per deciliter | 268.5 miligrams per deciliter |
| Baseline hematocrit | 32 Percent STANDARD_DEVIATION 3.4 | 32.1 Percent STANDARD_DEVIATION 2.9 | 31.9 Percent STANDARD_DEVIATION 4 |
| Baseline Hemoglobin (g/dl) | 10.6 g/dl (grams per deciliter) STANDARD_DEVIATION 1.2 | 10.6 g/dl (grams per deciliter) STANDARD_DEVIATION 1 | 10.6 g/dl (grams per deciliter) STANDARD_DEVIATION 1.4 |
| Baseline Platelets | 135 x 10^5 cells/mm^3 | 136 x 10^5 cells/mm^3 | 133 x 10^5 cells/mm^3 |
| Body Mass Index | 29 kg/m^2 | 31.2 kg/m^2 | 26.4 kg/m^2 |
| Height (cm) | 163 centimeters STANDARD_DEVIATION 11 | 165.9 centimeters STANDARD_DEVIATION 9.4 | 161.7 centimeters STANDARD_DEVIATION 11.6 |
| History of asthma | 6 Participants | 3 Participants | 3 Participants |
| History of atrial fibrillation | 1 Participants | 1 Participants | 0 Participants |
| History of coronary artery disease | 2 Participants | 0 Participants | 2 Participants |
| History of diabetes melitus | 10 Participants | 3 Participants | 7 Participants |
| History of hypertension | 34 Participants | 13 Participants | 21 Participants |
| History of obstructive sleep apnea | 8 Participants | 4 Participants | 4 Participants |
| History of peripheral vascular disease | 1 Participants | 1 Participants | 0 Participants |
| Medical History (none) | 18 Participants | 6 Participants | 12 Participants |
| Preoperative risk of major transfusion | 358 Percent | 212 Percent | 505 Percent |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 61 participants | 31 participants | 30 participants |
| Sex: Female, Male Female | 42 Participants | 21 Participants | 21 Participants |
| Sex: Female, Male Male | 19 Participants | 10 Participants | 9 Participants |
| Total number of vertebral levels | 13 Vertebra levels | 15 Vertebra levels | 10 Vertebra levels |
| Weight (kilogram) | 77 kilogram (kg) STANDARD_DEVIATION 20 | 82.1 kilogram (kg) STANDARD_DEVIATION 18.9 | 72.9 kilogram (kg) STANDARD_DEVIATION 21.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 9 / 31 | 9 / 30 |
Outcome results
Primary
Total Red Blood Cells Transfused in the Intraoperative Period
Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion.
Time frame: Intraoperative period (approximately 12 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Total Red Blood Cells Transfused in the Intraoperative Period | 1140 milliliters |
| Placebo | Total Red Blood Cells Transfused in the Intraoperative Period | 1460 milliliters |
p-value: 0.05Wilcoxon (Mann-Whitney)
Secondary
Additional Blood Products Transfused
Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units.
Time frame: 24 hours after skin incision
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tranexamic Acid | Additional Blood Products Transfused | 1 Units |
| Placebo | Additional Blood Products Transfused | 2 Units |
Secondary
Post Operative Major Morbidity
Number of participants who experienced arterial or venous thromboembolism, neurologic complications (including stroke, seizure,and delirium), infections, and pulmonary renal or cardiac adverse outcomes (demand ischemia, myocardial infarction or new arrhythmia) before another operative procedure or hospital discharge.
Time frame: Time of surgery to date of discharge from hospital (average 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid | Post Operative Major Morbidity | 9 Participants |
| Placebo | Post Operative Major Morbidity | 9 Participants |
Other Pre-specified
Estimated Intraoperative Blood Loss
Estimated Intraoperative blood loss in milliliters (mLs)
Time frame: Incision to skin closure (approximately 10 hours)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tranexamic Acid | Estimated Intraoperative Blood Loss | 1550 Milliliters |
| Placebo | Estimated Intraoperative Blood Loss | 1600 Milliliters |
Post Hoc
Total Operating Room Time
Total operating room time from incision to closure of incision in minutes.
Time frame: Minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Total Operating Room Time | 602 Minutes |
| Placebo | Total Operating Room Time | 576 Minutes |
Other Pre-specified
Total Tranexamic Acid Dose (mg)
Total milligrams of intravenous tranexamic acid administered during the surgical procedure.
Time frame: Intraoperative period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Total Tranexamic Acid Dose (mg) | 1408 milligrams |
| Placebo | Total Tranexamic Acid Dose (mg) | 0 milligrams |