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Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumors

Primary Purpose

Metastasis Spinal Tumor

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Tranexamic Acid
stroke-physiological saline solution (SPSS)
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastasis Spinal Tumor focused on measuring Tranexamic Acid, blood loss, seperation surgery

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the Second Affiliated Hospital Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tranexamic acid group

SPSS group

Arm Description

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；

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；

Outcomes

Primary Outcome Measures

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）
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)

Secondary Outcome Measures

allogeneic transfusion blood volume
amount of allogeneic transfusion blood volume needed during operation

Full Information

First Posted
August 29, 2023
Last Updated
September 1, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT06023212
Brief Title
Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumors
Official Title
Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor: a Single Center, Randomized Controlled Trial to Assess the Efficacy of Tranexamic Acid for Hemostasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastasis Spinal Tumor
Keywords
Tranexamic Acid, blood loss, seperation surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tranexamic acid group
Arm Type
Experimental
Arm Description
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；
Arm Title
SPSS group
Arm Type
Placebo Comparator
Arm Description
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；
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
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
Intervention Name(s)
stroke-physiological saline solution (SPSS)
Intervention Description
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 Outcome Measure Information:
Title
total blood loss
Description
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）
Time Frame
measured 3 days postoperatively
Title
Intraoperative blood loss
Description
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)
Time Frame
1 day (measured once after surgery)
Secondary Outcome Measure Information:
Title
allogeneic transfusion blood volume
Description
amount of allogeneic transfusion blood volume needed during operation
Time Frame
1 day (measured once during surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hengyuan Li, MD
Phone
13616519278
Email
hengyuanxiang007@163.com
Facility Information:
Facility Name
the Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
311200
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hengyuan Li, MD
Phone
13616519278
Email
hengyuanxiang007@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumors

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