Tranexamic Acid Clinical Trial
Official title:
The Efficacy and Safety of the Loading Dose of Tranexamic Acid in Scoliosis Surgery During Perioperative
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 |
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
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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