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

Study Overview
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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.

Official Title
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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

Conditions
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Metastasis Spinal Tumor

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: stroke-physiological saline solution (SPSS)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tranexamic acid group<br>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<br>* 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.<br>|
| Placebo Comparator: SPSS group<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allogeneic transfusion blood volume | amount of allogeneic transfusion blood volume needed during operation | 1 day (measured once during surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic Acid, blood loss, seperation surgery