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

Completed

• Conditions: Tranexamic Acid

• Registration Number: NCT04952285
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-06-27
• Last Update Submitted: 2021-06-27
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incision drainage Incision drainage Incision drainage after surgery	24 hours after surgery	Incision drainage after surgery
Intraoperative blood loss	At the end of the surgery	Intraoperative blood loss

Secondary Outcome Measures

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