Efficacy and Safety of Intravenous Tranexamic Acid on Perioperative Blood Loss in Spinal Metastasis Decompressive Surgery: A Double-blinded, Randomized, Placebo-controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240608003

Enrollment

108

Registered

2024-06-08

Start date

2024-03-29

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal metastasis occurs in approximately 15.67% of all cancer cases, with 1 in 10 of these patients experiencing nerve compression. This compression leads to sensory loss, muscle weakness, and loss of bowel and bladder control, significantly impacting patients&#039

Interventions

tranexamic acid 15 mg/kg intravenous 20 minute prior to surgery and then Tranexamic acid continuous drip 1 mg/kg/h until skin closure,normal saline intravenous same dose and rate

Experimental Drug,Experimental Drug

tranexamic acid,normal saline

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with metastatic spinal cord compression at the Thoracolumbar spine who have undergone laminectomy and instrumentation surgery.

Exclusion criteria

Exclusion criteria: 1. Patients who have not stopped antiplatelet or anticoagulant medication prior to surgery. 2. Presence of coagulopathy. 3. Platelet level less than 50,000 4. History of allergy to Tranexamic acid or contraindications to its use. 5. History of venous thromboembolic events. 6. Serum creatinine level more than and equal 2.5

Design outcomes

Primary

Measure	Time frame
amount of PRC transfusion at 72 hours after surgery unit and volume of PRC transfused	—

Secondary

Measure	Time frame
Estimated intraoperative blood loss During surgery Estimate by blood in suction device and weight of blood soaked swab ,Postoperative drainage volume After removed Radivac drain Total volume in Radivac drain ,Total Hb loss At 72 hours after surgery Hemoglobin level before surgery minus Hemoglobin level at 72 hours after surgery ,Total RBC volume loss 72 hours after surgery Calculated by Hemoglobin balanced formula,The number of patients who received blood transfusions 72 hours after surgery The number of patients who received blood transfusions.,Adverse events During hospitalization Observe and screening VTE by measure calf diameter and oxygen saturation once a day	—

Measure

Time frame

Estimated intraoperative blood loss During surgery Estimate by blood in suction device and weight of blood soaked swab ,Postoperative drainage volume After removed Radivac drain Total volume in Radivac drain ,Total Hb loss At 72 hours after surgery Hemoglobin level before surgery minus Hemoglobin level at 72 hours after surgery ,Total RBC volume loss 72 hours after surgery Calculated by Hemoglobin balanced formula,The number of patients who received blood transfusions 72 hours after surgery The number of patients who received blood transfusions.,Adverse events During hospitalization Observe and screening VTE by measure calf diameter and oxygen saturation once a day

—

Countries

Thailand

Contacts

Public ContactSirichai Wilartratsami

Mahidol university

sirichai_w@hotmail.com0813721107

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026