Tranexamic Acid Infusion During Elective Spine Surgery

NCT ID: NCT04312880

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-01-01

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.

Conditions

Spine Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Patient will receive no transexemic acid of any kind

Group Type: NO_INTERVENTION

No interventions assigned to this group

IV-transexemic acid

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

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

IV and topical form of TXA will be administered to patients in the respective groups.

Topical-transexemic acid

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

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

IV and topical form of TXA will be administered to patients in the respective groups.

Interventions

Tranexamic Acid

IV and topical form of TXA will be administered to patients in the respective groups.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Lawrence, MD

Role: PRINCIPAL_INVESTIGATOR

Attending Surgeon

Locations

Albany Medical Center

Albany, New York, United States

Countries

United States

Other Identifiers

5176

Identifier Type: -

Identifier Source: org_study_id