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Completed

NCT Number: NCT04952285

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.

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Key information

Conditions

Tranexamic Acid

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intraoperative blood loss

    Time frame: At the end of the surgery

    Intraoperative blood loss

  2. Incision drainage Incision drainage Incision drainage after surgery

    Time frame: 24 hours after surgery

    Incision drainage after surgery

Secondary outcomes

  1. Autologous blood doping

    Time frame: At the end of the surgery

    Recycle the blood during the intraoperative , back to the patient

  2. red blood cell transfusion

    Time frame: At the end of the surgery

    red blood cell transfusion

  3. Plasma infusion

    Time frame: At the end of the surgery

    Plasma infusion

  4. HB

    Time frame: Within 1 week before surgery；1 day after surgery

    hemoglobin

  5. WBC

    Time frame: Within 1 week before surgery；1 day after surgery

    White blood cells

  6. PTL

    Time frame: Within 1 week before surgery；1 day after surgery

    platelet

  7. PT

    Time frame: Within 1 week before surgery；1 day after surgery

    Prothrombin time

  8. APTT

    Time frame: Within 1 week before surgery；1 day after surgery

    activated partial thromboplastin time

  9. INR

    Time frame: Within 1 week before surgery；1 day after surgery

    International Normalized Ratio

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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