Clinical trial NCT04312880: Tranexamic Acid Infusion During Elective Spine Surgery
Official title: Tranexamic Acid Infusion During Elective Spine Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Spine Surgery
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Drain output
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Change in hematocrit
timeFrame: two days post operatively
measure: Change in hemoglobin
timeFrame: two days post operatively
measure: Emergency department visits
timeFrame: 30 days post operatively
measure: number of hospital readmissions
timeFrame: 30 days post operatively
measure: Incidence of PE
timeFrame: 30 days post opertively
measure: Incidence of DVT
timeFrame: 30 days post opertively
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Attending Surgeon
name: James Lawrence, MD
role: PRINCIPAL_INVESTIGATOR
References: