Tranexamic Acid Infusion During Elective Spine Surgery
- Registration Number
- NCT04312880
- Lead Sponsor
- Albany Medical College
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 65
- Patients undergoing decompressive lumbar laminectomy with or without fusion
- Primary surgical procedure
- Competent adult able to give informed consent
- Age >18
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical-transexemic acid Tranexamic Acid the wound site after the surgery is completed will be bathed in TXA for a standardized period of time prior to skin closure IV-transexemic acid Tranexamic Acid weight adjusted standard dose of TXA will be administered to these subset of patients prior to incision in IV-form
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence of DVT 30 days post opertively We will assess is any treatment arm had an increased risk of DVT
Change in hematocrit two days post operatively Labs will be recorded each morning after the surgery, this includes hematocrit
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
number of hospital readmissions 30 days post operatively We will assess which treatment arms, if any had increased rate of readmission to the hospital
Change in hemoglobin two days post operatively Labs will be recorded each morning after the surgery, this includes hemoglobin
Incidence of PE 30 days post opertively We will assess is any treatment arm had an increased risk of PE
Trial Locations
- Locations (1)
Albany Medical Center
🇺🇸Albany, New York, United States