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

Phase 1

Recruiting

• Conditions: Metastasis Spinal Tumor
• Interventions: Drug: stroke-physiological saline solution (SPSS); Drug: Tranexamic Acid

• Registration Number: NCT06023212
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-05
• Study Start: 2023-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-01-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPSS group	stroke-physiological saline solution (SPSS)	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；
tranexamic acid group	Tranexamic Acid	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；

Primary Outcome Measures

Name	Time	Method
total blood loss	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）
Intraoperative blood loss	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 Outcome Measures

Name	Time	Method
allogeneic transfusion blood volume	1 day (measured once during surgery)	amount of allogeneic transfusion blood volume needed during operation

Trial Locations

Locations (1)

the Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China