Tranexamic Acid Dosing in Adult Spinal Deformity Surgery
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|ClinicalTrials.gov Identifier: NCT02053363|
Recruitment Status : Recruiting
First Posted : February 3, 2014
Last Update Posted : January 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adult Spinal Deformity||Drug: Tranexamic Acid (Cyklokapron)||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Low Versus High Dose Tranexamic Acid in Adult Spinal Deformity Surgery: A Randomized, Blinded, Controlled Trial|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: 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.
Drug: Tranexamic Acid (Cyklokapron)
Active Comparator: 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.
Drug: Tranexamic Acid (Cyklokapron)
- Blood Loss [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1 week. ]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.
- Red Blood Cell Transfusions [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1 week. ]To compare the mean number of packed red blood cell (PRBC) transfusions given to the two groups.
- Complications [ Time Frame: 90 days ]To compare the rates of intraoperative complications and 90 day complications observed in the two groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053363
|Contact: Michael P Kelly, MD, MSCI(p)||email@example.com|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Elfaridah P. Frazier, PhD 314-747-2574 firstname.lastname@example.org|
|Principal Investigator: Michael P. Kelly, MD, MSCI(p)|
|Sub-Investigator: Lawrence Lenke, MD|
|Sub-Investigator: Keith Bridwell, MD|
|Principal Investigator:||Michael P. Kelly, MD, MSCI(p)||Washington University School of Medicine|