Tranexamic Acid Infusion During Elective Spine Surgery

Albany Medical College

Status and phase: Invitation-only; Phase 4

Conditions: Spine Surgery

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04312880

5176

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 3 patient groups

Control

No Intervention group

Description:

Patient will receive no transexemic acid of any kind

IV-transexemic acid

Experimental group

Description:

weight adjusted standard dose of TXA will be administered to these subset of patients prior to incision in IV-form

Treatment:

Drug: Tranexamic Acid

Topical-transexemic acid

Experimental group

Description:

the wound site after the surgery is completed will be bathed in TXA for a standardized period of time prior to skin closure

Treatment:

Drug: Tranexamic Acid