Clinical Trial Analyzing the Efficacy of Oral Administration of Tranexamic Acid in Spine Surgery.

NCT05705336 | Completed Phase 4 FDA Drug

• 1 other identifier: N0421
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Study design: Randomized control trial Purpose: Evaluate the efficacy of oral administration of tranexamic acid (TXA) in spine surgeries to achieve blood loss reduction. Methods. A total of 60 patients undergoing major surgery of the spine, were randomly assigned into 2 groups. Group 1 was assigned as the control group and the other one included oral administration of tranexamic acid 2 hours prior to surgery. Outcomes measures included intraoperative blood loss, postoperative blood loss, hematological parameters, blood transfusion needed, and surgical complications.

Conditions

Tranexamic Acid (TXA); Prospective Study; Evidence-based Medicine; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Total volume of blood loss

  Calculated as intraoperative blood loss plus drainage collection. It was calculated by the anesthesiologist at the end of the surgery, the anesthesiologist and surgeons in charge were blinded to the patient group. A suction drain was placed deep into the fascia before closure; the amount of total drainage was recorded.

  48 hours

Study Arms (2)

1. Tranexamic Acid Oral Product (n=30 cases)

ACTIVE COMPARATOR

Single dose of 1950 mg (3 tablets of 650 mg) was administered orally 2 hours before the surgical incision. The dose was administered by the nurse on duty who provided 100ml of water to swallow the pills.

Drug: Tranexamic Acid Oral Product

2. Placebo (30 cases)

PLACEBO COMPARATOR

Nursery team would provide 100ml of water, and 3 tablets of placebo pills administered 2 hours prior to surgery.

Drug: Placebo pills

Interventions

Tranexamic Acid Oral Product DRUG

Single dose of 1950 mg (3 tablets of 650 mg) was administered orally 2 hours before the surgical incision.

1. Tranexamic Acid Oral Product (n=30 cases)

Placebo pills DRUG

Single dose of 3 standard placebo pills administered orally 2 hours before the surgical incision.

2. Placebo (30 cases)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of 40-70 years
• Patients undergoing major surgery (it was defined as "surgeries involving the intervention of more than 4 levels of the thoracolumbar spine, and with a diagnosis of failed back surgery or, deformities in the spine")
• Complete data
• Agree to sign the informed consent

You may not qualify if:

• Patients excluded were those with low preoperative hemogram values (Hb \<10mg/dL, low platelet counts (\<100 x 109/L)
• Bleeding disorders, coagulopathies
• Intake of contraceptives or anticoagulant medication
• Active thromboembolic disease (deep venous thromboembolism, chronic venous insufficiency, chronic thromboembolism)
• Fibrinolytic disorders secondary to consumption coagulopathy
• History of thromboembolic or coronary disease
• History of seizure
• Liver failure
• Dyslipidemia
• Congenital coagulopathies (Von Willebrand Disease, Hemophilia A and B)
• Acquired coagulopathy (Vitamin K deficiency, disseminated intravascular coagulation)
• Thrombocytopenic purpura
• Patients in whom postsurgical hemoglobin was not available, or patients who accidentally removed the drain or had leaks were eliminated from the study

Sponsors & Collaborators

• Alejandro Reyes Sánchez: lead

Study Sites (1)

Alejandro Reyes Sánchez

Mexico City, 14389, Mexico

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients agreed to receive either placebo or medication, without knowing which they were getting
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Spine Surgery Chief

Model Details: 2 randomized groups

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 30, 2023
• Study Start: January 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 1, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)