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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04952285
Other study ID # 2021-0215
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2017

Study information

Verified date June 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative blood loss Intraoperative blood loss At the end of the surgery
Primary Incision drainage Incision drainage Incision drainage after surgery Incision drainage after surgery 24 hours after surgery
Secondary Autologous blood doping Recycle the blood during the intraoperative , back to the patient At the end of the surgery
Secondary red blood cell transfusion red blood cell transfusion At the end of the surgery
Secondary Plasma infusion Plasma infusion At the end of the surgery
Secondary HB hemoglobin Within 1 week before surgery;1 day after surgery
Secondary WBC White blood cells Within 1 week before surgery;1 day after surgery
Secondary PTL platelet Within 1 week before surgery;1 day after surgery
Secondary PT Prothrombin time Within 1 week before surgery;1 day after surgery
Secondary APTT activated partial thromboplastin time Within 1 week before surgery;1 day after surgery
Secondary INR International Normalized Ratio Within 1 week before surgery;1 day after surgery
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