Spine Surgery
Conditions
Brief summary
Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion.
Detailed description
This will be a prospective randomized control, double-blinded investigation. The Investigators will recruit patients undergoing elective, primary, decompressive lumbar surgery via a posterior surgical approach of less than 3 levels. This includes patients undergoing decompressive lumbar laminectomies with or without fusion. Fusion may include posterior interbody and/or posterior lateral techniques with instrumentation. There will be 3 treatment arms with the goal of 65 patients in each arm. Patients will be randomized pre-operatively and enrolled into the IV transexamic acid group (receiving intraoperative intravenous tranexamic acid infusion), or the topical transexamic acid group or the control/placebo group (receiving intraoperative intravenous saline). The Investigators expect the duration of each treatment group to be approximately 4-5 months. Therefore, the study should be completed within 1.5 years. The primary surgeon and anesthesia staff will not be blinded to the treatment arm due to the nature of the different administration routes, but post-operative nursing staff will be blinded to administration routes.
Interventions
DRUGTranexamic Acid
IV and topical form of TXA will be administered to patients in the respective groups.
Sponsors
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing decompressive lumbar laminectomy with or without fusion * Primary surgical procedure * Competent adult able to give informed consent * Age \>18
Exclusion criteria
* h/o DVT or PE * h/o seizure * h/o coagulopathy * Diagnosis of malignancy or infection as indication for surgical decompression * Abnormal pre-operative PT/INR, aPTT, bleeding time * Platelet count \< 100 * Patients requiring therapeutic heparin or lovenox bridges prior to and/or after surgery * Allergy to TXA * Pregnant women and prisoners * Renal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drain output | 48 hours postoperatively | Drains will be placed during surgery, this will be recorded by nursing staff on a regular schedule and we will assess the results as a surrogate for blood loss post operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin | two days post operatively | Labs will be recorded each morning after the surgery, this includes hemoglobin |
| Emergency department visits | 30 days post operatively | We will assess which treatment arms, if any had increased rate of Emergency department visits for any reason |
| Change in hematocrit | two days post operatively | Labs will be recorded each morning after the surgery, this includes hematocrit |
| Incidence of PE | 30 days post opertively | We will assess is any treatment arm had an increased risk of PE |
| Incidence of DVT | 30 days post opertively | We will assess is any treatment arm had an increased risk of DVT |
| number of hospital readmissions | 30 days post operatively | We will assess which treatment arms, if any had increased rate of readmission to the hospital |
Countries
United States
Outcome results
None listed