Tranexamic Acid Dosing in Adult Spinal Deformity Surgery

Study Overview
=================
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: Low Dose (Standard of Care/Control): Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion 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.

Official Title
-----------------
Low Versus High Dose Tranexamic Acid in Adult Spinal Deformity Surgery: A Randomized, Blinded, Controlled Trial

Conditions
-----------------
Adult Spinal Deformity

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid (Cyklokapron)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose/Study Group<br>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. | Drug: Tranexamic Acid (Cyklokapron)<br> <br> |
| Active Comparator: Standard of Care/Control<br>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. | Drug: Tranexamic Acid (Cyklokapron)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | This outcome is measured during surgery, from exposure to wound closure, approximately 8 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 
| 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. | Perioperative complications were defined as complications occurring within 90 days of surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tranexamic acid, reconstructive spine surgery