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Completed

NCT Number: NCT03804697

Selective Thromboembolism Prophylaxis After Arthroplasty

Asian populations have a lower rate of high-risk gene mutations of venous thrombosis, which means a reasonable perioperative anticoagulant management after hip or knee arthroplasty for Caucasian populations may be too excessive for Asians. So, individual patient risk assessment, rather than a "blanket policy", is considered the best thromboembolism prophylaxis for Asians.The purpose of this study was to evaluate the effectiveness and safety of selective thromboembolism prophylaxis compared with conventional thromboembolism prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty for Asian populations.

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Key information

About this study

Asian patients who underwent hip or knee arthroplasty in Guangdong General Hospital from August 2016 to August 2017 were randomly divided into selective anticoagulation group (SAG) and conventional anticoagulation group (CAG). SAG used anticoagulant when TEG indicated hypercoagulability while CAP used anticoagulant until one month after surgery regularly. Data including patients' basic information, postoperative complications, perioperative clotting index, intraoperative blood loss, perioperative TEG, volume of drainage, and blood transfusion were evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • over 18 years of age,
  • ASA Ⅰ-Ⅱ grade,
  • BMI <40Kg / M ^ 2
  • Underwent total knee arthroplasty/ total hip arthroplasty in Guangdong General Hospital
  • consent to enroll in this study

Exclusion criteria

  • history of VTE, preoperative infection, preoperative coagulation
  • liver and kidney function existed clinically abnormalities
  • history of tumor
  • history of vascular surgery
  • heart infarction or cerebral infarction within 6 months
  • history of lower extremity surgery within 3 months

Treatment and study plan

selective anticoagulation

Drug

Selective anticoagulation group used anticoagulant once thromboelastography indicated hypercoagulable state. Conventional anticoagulation group used anticoagulant until one month after surgery routinely. The main difference was that the experimental group did not use anticoagulation if the thromboelastography indicated that the blood coagulation status was normal while the control group use anticoagulation routinely.

Other names: Thromboelastography

Primary outcomes

  1. The Incidence of Deep Vein Thrombosis

    Time frame: 1 day after surgery

    Measured by ultrasound,

  2. The Incidence of Deep Vein Thrombosis

    Time frame: 3 days after surgery

    Measured by ultrasound

  3. The Incidence of Deep Vein Thrombosis

    Time frame: 5 days after surgery

    Measured by ultrasound

  4. The Incidence of Deep Vein Thrombosis

    Time frame: 1 month after surgery

    Measured by ultrasound

  5. The Incidence of Deep Vein Thrombosis

    Time frame: 3 months after surgery

    Measured by ultrasound

  6. The Incidence of Deep Vein Thrombosis

    Time frame: 6 months after surgery

    Measured by ultrasound

Secondary outcomes

  1. Hematocrit

    Time frame: 1 day before surgery

    Measured by Complete Blood Count

  2. Hematocrit

    Time frame: 1 day after surgery

    Measured by Complete Blood Count

  3. Hematocrit

    Time frame: 3 days after surgery

    Measured by Complete Blood Count

  4. Hematocrit

    Time frame: 5 days after surgery

    Measured by Complete Blood Count

  5. Hemoglobin

    Time frame: 1 day before surgery

    Number of Hemoglobin Measured by Blood Test

  6. Hemoglobin

    Time frame: 1 day after surgery

    Number of Hemoglobin Measured by Blood Test

  7. Hemoglobin

    Time frame: 3 days after surgery

    Number of Hemoglobin Measured by Blood Test

  8. Hemoglobin

    Time frame: 5 days after surgery

    Number of Hemoglobin Measured by Blood Test

  9. Red Blood Cell

    Time frame: 1 day before surgery

    Number of Red Blood Cell Measured by Complete Blood Count

  10. Red Blood Cell

    Time frame: 1 day after surgery

    Number of Red Blood Cell Measured by Complete Blood Count

  11. Red Blood Cell

    Time frame: 3 days after surgery

    Number of Red Blood Cell Measured by Complete Blood Count

  12. Red Blood Cell

    Time frame: 5 days after surgery

    Number of Red Blood Cell Measured by Complete Blood Count

  13. Volume of Transfusion

    Time frame: During Hospitalization

    Volume of Blood Transfusion

  14. Transfusion Rate

    Time frame: During Hospitalization

    Number of patients who receive transfusion divided by total number of patients in the group

  15. Superficial Infection

    Time frame: During Hospitalization

    Number of patients who suffer superficial infection

  16. Superficial Infection

    Time frame: 1 month after surgery

    Number of patients who suffer superficial infection

  17. Superficial Infection

    Time frame: 3 months after surgery

    Number of patients who suffer superficial infection

  18. Superficial Infection

    Time frame: 6 months after surgery

    Number of patients who suffer superficial infection

  19. Deep Infection

    Time frame: During Hospitalization

    Number of patients who suffer deep infection

  20. Deep Infection

    Time frame: 1 month after surgery

    Number of patients who suffer deep infection

  21. Deep Infection

    Time frame: 3 months after surgery

    Number of patients who suffer deep infection

  22. Deep Infection

    Time frame: 6 months after surgery

    Number of patients who suffer deep infection

  23. Ecchymosis incidence Rate

    Time frame: 1 month after surgery

    Number of patients who suffer ecchymosis divided by total number of patients in the group

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

Selective Thromboembolism Prophylaxis After Total Hip Arthroplasty or Total Knee Arthroplasty by a Risk Stratification With Thromboelastography for Asian Populations: A Randomized Control Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 15, 2019
Registry last updated
Jan 15, 2019

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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