The Efficacy and Safety of the Loading Dose of Tranexamic Acid in Scoliosis Surgery During Perioperative

This study intends to make full use of the advantage of spinal orthopedic surgery in our medical center.Analyze the blood loss and blood coagulation function and the influence of safety of load dose tranexamic acid (TXA) in scoliosis surgery during perioperative.

Study Overview

• Status: Completed
• Conditions: Tranexamic Acid

• Study Type: Observational
• Enrollment (Actual): 207

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

age:18-60 years old；American Society of Anesthesiologists (ASA):I-II；The spinal orthopedic undergoing elective surgery

Description

Inclusion Criteria:

• age:18-60 years old
• American Society of Anesthesiologists (ASA):I-II
• The spinal orthopedic undergoing elective surgery

Exclusion Criteria:

• Severe cardiopulmonary dysfunction
• Blood coagulation dysfunction
• Disorders of liver and kidney function
• Tranexamic acid allergies
• The history of pulmonary embolism and venous thrombosis of lower limbs
• Anticoagulant drugs and nonsteroidal anti-inflammatory drugs in 7 days

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Normal saline（I）; Intravenous infusion of 0.9% saline when start to cut the skin，do not intravenous tranexamic acid during the surgery
Tranexamic acid（II）; Intravenous infusion of tranexamic acid 1g when start to cut the skin in 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	Intraoperative blood loss	At the end of the surgery
Incision drainage Incision drainage Incision drainage after surgery	Incision drainage after surgery	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autologous blood doping	Recycle the blood during the intraoperative , back to the patient	At the end of the surgery
red blood cell transfusion	red blood cell transfusion	At the end of the surgery
Plasma infusion	Plasma infusion	At the end of the surgery
HB	hemoglobin	Within 1 week before surgery；1 day after surgery
WBC	White blood cells	Within 1 week before surgery；1 day after surgery
PTL	platelet	Within 1 week before surgery；1 day after surgery
PT	Prothrombin time	Within 1 week before surgery；1 day after surgery
APTT	activated partial thromboplastin time	Within 1 week before surgery；1 day after surgery
INR	International Normalized Ratio	Within 1 week before surgery；1 day after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: tranexamic acid; Blood conservation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2021-0215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No