Actively Recruiting

Phase 1
Phase 2
Age: 10Years - 80Years
All Genders
ID06023212

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10

150

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of tranexamic acid to reduce bleeding during and after surgery for metastatic spinal tumors in patients with lung cancer. This clinical trial aims to compare bleeding amounts between patients receiving tranexamic acid and those who do not, addressing the risk of severe complications caused by massive blood loss during tumor removal. The study is conducted as a triple-blinded, randomized controlled trial to assess the effectiveness of tranexamic acid for controlling bleeding. Participants are randomly assigned to one of two groups. One group receives an intravenous drip of tranexamic acid before the incision, tranexamic acid-soaked gauze applied to the wound before closure, and intravenous tranexamic acid three times within 24 hours after surgery. The other group receives a similar procedure using a saline solution as a placebo. Treatments are given around the time of surgery to compare their effects on blood loss. During the study, researchers measure total blood loss over three days after surgery and intraoperative blood loss once after surgery. They also track the volume of blood transfusions given during surgery. Participant health and bleeding outcomes are closely monitored to evaluate the treatment's impact. The study runs from December 2023 to August 2026 and includes patients aged 10 to 80 years who undergo specific spinal tumor surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 10Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed as metastatic carcinoma of the thoracolumbar spine
  • Solitary neoplasm involving only one segment of spine
  • Patients undergoing separation surgery
Not Eligible

You will not qualify if you...

  • Abnormal coagulation function before surgery
  • Allergy to tranexamic acid
  • Neoplasm involving more than one segment of spine
  • Patients with rich blood supply who need embolization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 24 hours during and after surgery

Participants receive tranexamic acid or placebo during and shortly after surgery to prevent bleeding.

1 surgery day and administration of medication over 24 hours post-surgery

Follow-up

Duration - 3 days postoperatively

Participants are monitored for blood loss and other outcomes after surgery.

1 visit 3 days after surgery

Trial Site Locations

Total: 1 location

1

the Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 311200

Actively Recruiting

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Research Team

H

Hengyuan Li, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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