RecruitingPhase 1Phase 2NCT06023212

Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients

Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients: a Triple Blinded, Randomized Controlled Trial to Assess the Efficacy of Tranexamic Acid for Hemostasis


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

150 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Massive blood loss occurs in metastatic spinal tumor resection and may cause severe complications. The objective of this study is to investigate whether the use of tranexamic acid will reduce perioperative and postoperative bleeding when compared to those without use of tranexamic acid.


Eligibility

Min Age: 10 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a medication called tranexamic acid can reduce dangerous bleeding during surgery to remove a lung cancer tumor that has spread to the spine. Spinal surgery for cancer can involve significant blood loss, and tranexamic acid helps blood clot more effectively. **You may be eligible if...** - You have lung cancer that has spread (metastasized) to one segment of your thoracic or lumbar spine - You are scheduled for a type of spinal surgery called separation surgery **You may NOT be eligible if...** - You have abnormal blood clotting before surgery - You are allergic to tranexamic acid - The tumor affects more than one segment of your spine - Your tumor has a very rich blood supply and you need a procedure (embolization) to reduce blood flow beforehand Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTranexamic Acid

IV drip of 2 bottles of tranexamic acid (2g) before making incision during surgery; 1g tranexamic acid soaked gauze applied to the wound for 5 minintes before suture; patients were administered IV drip of tranexamic acid 3 times (every 8 hours)within 24 hours after surgery.

DRUGstroke-physiological saline solution (SPSS)

IV drip of 2 bottles of saline before making incision during surgery; saline soaked gauze applied to the wound for 5 minintes before suture; patients were administered IV drip of saline 3 times (every 8 hours)within 24 hours after surgery.


Locations(1)

the Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06023212