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NCT Number: NCT06023212

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

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.

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Key information

Conditions

Metastasis Spinal Tumor Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

the Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 311200, China

Location status: Recruiting

Location contact

Hengyuan Li, MD

CONTACT

[email protected]

13616519278

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

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.

stroke-physiological saline solution (SPSS)

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.

Primary outcomes

  1. total blood loss

    Time frame: measured 3 days postoperatively

    the loss of total blood volume caused by various operations (mainly during surgical operations) throughout the entire treatment process.

    Total blood volume = preoperative blood volume *（preoperative hematocrit - hematocrit 3 days postoperatively）

  2. Intraoperative blood loss

    Time frame: 1 day (measured once after surgery)

    Refers to the total blood loss of a patient experienced during operation from skin incision to wound suture.

    Intraoperative blood loss = intraoperative drainage volume - intraoperative flushing volume + blood loss estimation using gauze (calculated as 10 cm × 10 cm gauze absorbs 10 ml)

Secondary outcomes

  1. allogeneic transfusion blood volume

    Time frame: 1 day (measured once during surgery)

    amount of allogeneic transfusion blood volume needed during operation

Study contacts

Contact information is provided by the study sponsor or research team.

Hengyuan Li, MD

CONTACT

[email protected]

13616519278

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2023
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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