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

NCT06023212 | Recruiting Phase 1

• 1 other identifier: 2022_LHY
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastasis Spinal Tumor

Keywords

Tranexamic Acid; blood loss; seperation surgery

Outcome Measures

Primary Outcomes (2)

• total blood loss

  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）

  measured 3 days postoperatively

• Intraoperative blood loss

  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)

  1 day (measured once after surgery)

Secondary Outcomes (1)

• allogeneic transfusion blood volume

  1 day (measured once during surgery)

Study Arms (2)

tranexamic acid group

EXPERIMENTAL

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；

Drug: Tranexamic Acid

SPSS group

PLACEBO COMPARATOR

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；

Drug: stroke-physiological saline solution (SPSS)

Interventions

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.

tranexamic acid group

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.

SPSS group

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 311200, China

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Hengyuan Li, MD

CONTACT

13616519278; hengyuanxiang007@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: December 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

CN (1)