Clincosm LogoSign in Get a demo

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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT04952285
Collaborator
(none)
207
Enrollment
36
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    207 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    The Efficacy and Safety of the Loading Dose of Tranexamic Acid in Scoliosis Surgery During Perioperative
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Dec 31, 2017
    Actual Study Completion Date :
    Dec 31, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Intraoperative blood loss [At the end of the surgery]

      Intraoperative blood loss

    2. Incision drainage Incision drainage Incision drainage after surgery [24 hours after surgery]

      Incision drainage after surgery

    Secondary Outcome Measures

    1. Autologous blood doping [At the end of the surgery]

      Recycle the blood during the intraoperative , back to the patient

    2. red blood cell transfusion [At the end of the surgery]

      red blood cell transfusion

    3. Plasma infusion [At the end of the surgery]

      Plasma infusion

    4. HB [Within 1 week before surgery；1 day after surgery]

      hemoglobin

    5. WBC [Within 1 week before surgery；1 day after surgery]

      White blood cells

    6. PTL [Within 1 week before surgery；1 day after surgery]

      platelet

    7. PT [Within 1 week before surgery；1 day after surgery]

      Prothrombin time

    8. APTT [Within 1 week before surgery；1 day after surgery]

      activated partial thromboplastin time

    9. INR [Within 1 week before surgery；1 day after surgery]

      International Normalized Ratio

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04952285
    Other Study ID Numbers:
    • 2021-0215
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
    tranexamic acid
    Blood conservation
    Additional relevant MeSH terms:
    Scoliosis

    Study Results

    No Results Posted as of Jul 7, 2021