Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery

NCT ID: NCT03037515

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2018-07-16

Brief Summary

The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion.

Detailed Description

Spine surgery is associated with large amount of perioperative blood loss. Factors influencing blood loss include surgical technique, operative time, number of vertebral levels arthrodesed, and others. Significant blood loss is associated with complications such as hypotension, end organ damage, or coagulopathy. Blood transfusions can increase risks of infection, blood incompatibility, and allergic reactions. Due to the significant risks and complications associated with blood loss and allogenic transfusions, efforts to identify safe and effective ways of lowering blood loss during spine surgery are crucial. Many methods have been utilized to reduce allogenic blood transfusions, such as autologous blood predonation, antifibrinolytic drugs, acute normovolemic hemodilution, intraoperative blood salvage, and others. Furthermore, the administration of antifibrinolytics, such as tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA), has been shown to reduce bleeding in cardiac, gynecological, urologic and total joint replacement surgeries. There have been many published studies investigating various antifibrinolytic agents such as TXA, EACA, and aprotinin. While aprotinin was shown to increase mortality rate in patients following cardiac surgery, TXA and EACA have not been shown to cause any substantial morbidity or to increase rate of thromboembolic events. Although IV TXA has been shown to be effective in reducing blood loss and transfusions in patients undergoing spine surgery, no studies in the literature have investigated the efficacy of PO TXA in decreasing blood loss and transfusions. The investigators believe that PO TXA will be just as efficacious and more cost-effective in reducing blood loss and transfusion needs in patients undergoing lumbar spine surgery.

The ultimate goal is identifying the most cost-effective protocol to decrease blood loss and need for transfusion. If oral TXA is found to be as efficacious as IV TXA in reducing blood loss and need for transfusion, significant cost savings can be achieved for the patient and the health care system in general.

Conditions

Blood Loss, Surgical; Blood Loss Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intravenous Tranexamic Acid

The IV TXA group will receive the standard dosing for our institution of 1 g TXA (diluted in 100 mL normal saline) given as an IV bolus immediately before incision and another 1 g TXA given before closure.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.

Oral Tranexamic Acid

The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.

Interventions

Tranexamic Acid

To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.

Intervention Type: DRUG

Other Intervention Names

Lysteda

Eligibility Criteria

Inclusion Criteria

• Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision)
• Must be able to swallow tablets

Exclusion Criteria

• Known allergy to TXA
• History of renal failure or kidney transplant
• History of arterial thromboembolic event (eg. myocardial infarction, stroke) within the past year
• Placement of an arterial stent within the past year
• History of blood clots (DVT, PE) within the past year
• Refusal to receive blood products

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Charles S Day

Orthopaedic Spine Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Health System

Detroit, Michigan, United States

Countries

United States

References

Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.

Reference Type: BACKGROUND

PMID: 21936146 (View on PubMed)

Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.

Reference Type: BACKGROUND

PMID: 12697586 (View on PubMed)

Other Identifiers

10608

Identifier Type: -

Identifier Source: org_study_id