Tranexamic Acid Dosing in Adult Spinal Deformity Surgery

The Washington University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Adult Spinal Deformity

Treatments: Drug: Tranexamic Acid (Cyklokapron)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02053363

201312010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

High Dose/Study Group

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid (Cyklokapron)

Standard of Care/Control

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid (Cyklokapron)