Adult Spinal Deformity
Conditions
Keywords
tranexamic acid, reconstructive spine surgery
Brief summary
The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.
Detailed description
After consent is obtained and the patient is enrolled in the trial, patients will be assigned de-identified, unique identification (ID) numbers. Randomization of these IDs to either low or high dose TXA will occur via a computer generated random assignment. Given the variations that may exist in surgical technique (e.g. performance of osteotomies), stratified randomization will be performed by attending surgeon. Based upon the randomization, the pharmacy will prepare TXA for one of two intravenous dosing protocols: 1. Low Dose (Standard of Care/Control): Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion 2. High Dose (Study Group): Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The surgeon, anesthesia team, and operating room staff will be blind to the concentration of TXA in the medications received. Treatments may be unblinded at the discretion of the surgeon and anesthesiologist, in cases of extreme blood loss. If additional anti-fibrinolytics are given, the change in dose will be recorded. Post-operative care will be the same as any other patient and data collection will be information contained in the patient's medical record that is part of routine, standard of care.
Interventions
Sponsors
AOSpine North America
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (ages 18-75) scheduled to undergo long segment (greater than 8 motion segments) posterior spinal fusion with instrumentation (PSF) for adult scoliosis
Exclusion criteria
* Patients with acquired defective color vision * Subarachnoid hemorrhage * Active intravascular clotting * Hypersensitivity to tranexamic acid or any of the ingredients * Patients who pre-donate autologous blood for intra- or post-operative use (Directed donor units are acceptable) * History of suspected blood disorders or abnormal coagulation laboratory results * Current anticoagulation therapy that cannot be interrupted * History of deep vein thrombosis (DVT) * Impaired renal function or creatinine clearance \<60 ml/min * Pregnancy or women who are lactating/breastfeeding * Women on hormonal contraceptives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | This outcome is measured during surgery, from exposure to wound closure, approximately 8 hours. | To compare the estimated blood loss in patients undergoing complex, reconstructive, spinal fusion surgeries receiving one of two dosing protocols for the anti-fibrinolytic, TXA. Estimated blood loss was calculated by suction canister volume minus intraoperative irrigation fluid plus blood content in sponges as estimated by weight for all cases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Red Blood Cell Transfusions | Participants will be followed for the duration of their hospital stay measured from day of surgery to day of discharge from the hospital, approximately 7 days. | To compare the mean volume (mL) of packed red blood cell (PRBC) transfusions given to the two groups. Volumes of RBC vary from bag to bag and real volumes will be recorded as provided by the blood bank. |
| Number of Patients Sustaining Intraoperative or 90 Day Complications | Perioperative complications were defined as complications occurring within 90 days of surgery. | To compare the rates of intraoperative complications and 90 day complications observed in the two groups. |
Countries
United States
Participant flow
Pre-assignment details
12 Patients consented to participation but withdrew prior to randomization and treatment assignment. Patients either elected not to proceed with the study, did not have surgery, or the proposed surgeries were changed and they were no longer eligible for participation.
Participants by arm
| Arm | Count |
|---|---|
| High Dose/Study Group Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron) | 25 |
| Standard of Care/Control Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron) | 27 |
| Total | 52 |
Baseline characteristics
| Characteristic | Standard of Care/Control | Total | High Dose/Study Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 18 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 34 Participants | 16 Participants |
| Age, Continuous | 56.7 years STANDARD_DEVIATION 14.3 | 58.3 years STANDARD_DEVIATION 12.1 | 59.8 years STANDARD_DEVIATION 9.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 27 participants | 52 participants | 25 participants |
| Sex: Female, Male Female | 23 Participants | 37 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 15 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 3 / 25 | 4 / 27 |
| serious Total, serious adverse events | 2 / 25 | 3 / 27 |
Outcome results
Primary
Blood Loss
To compare the estimated blood loss in patients undergoing complex, reconstructive, spinal fusion surgeries receiving one of two dosing protocols for the anti-fibrinolytic, TXA. Estimated blood loss was calculated by suction canister volume minus intraoperative irrigation fluid plus blood content in sponges as estimated by weight for all cases.
Time frame: This outcome is measured during surgery, from exposure to wound closure, approximately 8 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose/Study Group | Blood Loss | 2046 mL | Standard Deviation 1104 |
| Standard of Care/Control | Blood Loss | 1596 mL | Standard Deviation 933 |
Secondary
Number of Patients Sustaining Intraoperative or 90 Day Complications
To compare the rates of intraoperative complications and 90 day complications observed in the two groups.
Time frame: Perioperative complications were defined as complications occurring within 90 days of surgery.
Population: All patients achieved 90 day followup
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose/Study Group | Number of Patients Sustaining Intraoperative or 90 Day Complications | 2 Participants |
| Standard of Care/Control | Number of Patients Sustaining Intraoperative or 90 Day Complications | 3 Participants |
Secondary
Red Blood Cell Transfusions
To compare the mean volume (mL) of packed red blood cell (PRBC) transfusions given to the two groups. Volumes of RBC vary from bag to bag and real volumes will be recorded as provided by the blood bank.
Time frame: Participants will be followed for the duration of their hospital stay measured from day of surgery to day of discharge from the hospital, approximately 7 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose/Study Group | Red Blood Cell Transfusions | 1259 mL | Standard Deviation 868 |
| Standard of Care/Control | Red Blood Cell Transfusions | 935 mL | Standard Deviation 630 |