Tranexamic Acid Dosing in Adult Spinal Deformity Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/28/2019 |
| Start Date: | March 2014 |
| End Date: | December 2019 |
| Contact: | Michael P Kelly, MD, MSCI(p) |
| Email: | kellymi@wudosis.wustl.edu |
| Phone: | 314-747-2535 |
Low Versus High Dose Tranexamic Acid in Adult Spinal Deformity Surgery: A Randomized, Blinded, Controlled Trial
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.
anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex,
reconstructive spinal fusion surgeries.
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.
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.
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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Michael P. Kelly, MD, MSCI(p)
Phone: 314-747-2574
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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