Tranexamic Acid Infusion During Elective Spine Surgery

Spine Surgery Clinical Trial

Official title:

Tranexamic Acid Infusion During Elective Spine Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04312880
• Other study ID #: 5176
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: August 2020
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 65
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Drug:
• Tranexamic Acid
IV and topical form of TXA will be administered to patients in the respective groups.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drain output	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	48 hours postoperatively
Secondary	Change in hematocrit	Labs will be recorded each morning after the surgery, this includes hematocrit	two days post operatively
Secondary	Change in hemoglobin	Labs will be recorded each morning after the surgery, this includes hemoglobin	two days post operatively
Secondary	Emergency department visits	We will assess which treatment arms, if any had increased rate of Emergency department visits for any reason	30 days post operatively
Secondary	number of hospital readmissions	We will assess which treatment arms, if any had increased rate of readmission to the hospital	30 days post operatively
Secondary	Incidence of PE	We will assess is any treatment arm had an increased risk of PE	30 days post opertively
Secondary	Incidence of DVT	We will assess is any treatment arm had an increased risk of DVT	30 days post opertively