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

NCT ID: NCT06023212

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Metastasis Spinal Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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tranexamic acid group

injection of 2 bottles of tranexamic acid (1g/bottle) before making incision; tranexamic acid soaked gauze applied to the wound before closing the wound; Intravenous injection of tranexamic acid 3 times (every 8 hours)within 24 hours after operation;

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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.

SPSS group

injection of 2 bottles of stroke-physiological saline solution(SPSS)before making incision; SPSS soaked gauze applied to the wound before closing the wound; Intravenous injection of SPSS 3 times (every 8 hours)within 24 hours after operation;

Group Type PLACEBO_COMPARATOR

stroke-physiological saline solution (SPSS)

Intervention Type DRUG

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.

Interventions

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Tranexamic 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.

Intervention Type DRUG

stroke-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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed as metastatic carcinoma of the thoracolumbar spine
* solitary neoplasm involve only one segment of spine
* patients underwent separation surgery

Exclusion Criteria

* coagulation function was abnormal preoperatively
* patients are allergic to tranexamic acid
* neoplasm involve more than one segment of spine
* patients with rich blood supply who need embolization
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hengyuan Li, MD

Role: CONTACT

13616519278

Facility Contacts

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Hengyuan Li, MD

Role: primary

13616519278

Other Identifiers

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2022_LHY

Identifier Type: -

Identifier Source: org_study_id

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