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Selective Thromboembolism Prophylaxis After Arthroplasty

Primary Purpose

Venous Thrombosis, Deep, Arthroplasty Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
selective anticoagulation
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thrombosis, Deep

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    selective anticoagulation group

    conventional anticoagulation group

    Arm Description

    Selective anticoagulation group used anticoagulant when thromboelastogram(TEG) indicated hypercoagulability. TEG was performed 1 day before the surgery, 1 day after the surgery, 3 days after the surgery, and 5 days after the surgery. The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.

    The Intervention for conventional anticoagulation group was using anticoagulant until one month after surgery routinely. The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.

    Outcomes

    Primary Outcome Measures

    The Incidence of Deep Vein Thrombosis
    Measured by ultrasound,
    The Incidence of Deep Vein Thrombosis
    Measured by ultrasound
    The Incidence of Deep Vein Thrombosis
    Measured by ultrasound
    The Incidence of Deep Vein Thrombosis
    Measured by ultrasound
    The Incidence of Deep Vein Thrombosis
    Measured by ultrasound
    The Incidence of Deep Vein Thrombosis
    Measured by ultrasound

    Secondary Outcome Measures

    Hematocrit
    Measured by Complete Blood Count
    Hematocrit
    Measured by Complete Blood Count
    Hematocrit
    Measured by Complete Blood Count
    Hematocrit
    Measured by Complete Blood Count
    Hemoglobin
    Number of Hemoglobin Measured by Blood Test
    Hemoglobin
    Number of Hemoglobin Measured by Blood Test
    Hemoglobin
    Number of Hemoglobin Measured by Blood Test
    Hemoglobin
    Number of Hemoglobin Measured by Blood Test
    Red Blood Cell
    Number of Red Blood Cell Measured by Complete Blood Count
    Red Blood Cell
    Number of Red Blood Cell Measured by Complete Blood Count
    Red Blood Cell
    Number of Red Blood Cell Measured by Complete Blood Count
    Red Blood Cell
    Number of Red Blood Cell Measured by Complete Blood Count
    Volume of Transfusion
    Volume of Blood Transfusion
    Transfusion Rate
    Number of patients who receive transfusion divided by total number of patients in the group
    Superficial Infection
    Number of patients who suffer superficial infection
    Superficial Infection
    Number of patients who suffer superficial infection
    Superficial Infection
    Number of patients who suffer superficial infection
    Superficial Infection
    Number of patients who suffer superficial infection
    Deep Infection
    Number of patients who suffer deep infection
    Deep Infection
    Number of patients who suffer deep infection
    Deep Infection
    Number of patients who suffer deep infection
    Deep Infection
    Number of patients who suffer deep infection
    Ecchymosis incidence Rate
    Number of patients who suffer ecchymosis divided by total number of patients in the group

    Full Information

    First Posted
    December 28, 2018
    Last Updated
    January 13, 2019
    Sponsor
    Guangdong Provincial People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03804697
    Brief Title
    Selective Thromboembolism Prophylaxis After Arthroplasty
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    August 31, 2017 (Actual)
    Study Completion Date
    January 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guangdong Provincial People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Thrombosis, Deep, Arthroplasty Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    197 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    selective anticoagulation group
    Arm Type
    Experimental
    Arm Description
    Selective anticoagulation group used anticoagulant when thromboelastogram(TEG) indicated hypercoagulability. TEG was performed 1 day before the surgery, 1 day after the surgery, 3 days after the surgery, and 5 days after the surgery. The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.
    Arm Title
    conventional anticoagulation group
    Arm Type
    Active Comparator
    Arm Description
    The Intervention for conventional anticoagulation group was using anticoagulant until one month after surgery routinely. The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    selective anticoagulation
    Other Intervention Name(s)
    Thromboelastography
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The Incidence of Deep Vein Thrombosis
    Description
    Measured by ultrasound,
    Time Frame
    1 day after surgery
    Title
    The Incidence of Deep Vein Thrombosis
    Description
    Measured by ultrasound
    Time Frame
    3 days after surgery
    Title
    The Incidence of Deep Vein Thrombosis
    Description
    Measured by ultrasound
    Time Frame
    5 days after surgery
    Title
    The Incidence of Deep Vein Thrombosis
    Description
    Measured by ultrasound
    Time Frame
    1 month after surgery
    Title
    The Incidence of Deep Vein Thrombosis
    Description
    Measured by ultrasound
    Time Frame
    3 months after surgery
    Title
    The Incidence of Deep Vein Thrombosis
    Description
    Measured by ultrasound
    Time Frame
    6 months after surgery
    Secondary Outcome Measure Information:
    Title
    Hematocrit
    Description
    Measured by Complete Blood Count
    Time Frame
    1 day before surgery
    Title
    Hematocrit
    Description
    Measured by Complete Blood Count
    Time Frame
    1 day after surgery
    Title
    Hematocrit
    Description
    Measured by Complete Blood Count
    Time Frame
    3 days after surgery
    Title
    Hematocrit
    Description
    Measured by Complete Blood Count
    Time Frame
    5 days after surgery
    Title
    Hemoglobin
    Description
    Number of Hemoglobin Measured by Blood Test
    Time Frame
    1 day before surgery
    Title
    Hemoglobin
    Description
    Number of Hemoglobin Measured by Blood Test
    Time Frame
    1 day after surgery
    Title
    Hemoglobin
    Description
    Number of Hemoglobin Measured by Blood Test
    Time Frame
    3 days after surgery
    Title
    Hemoglobin
    Description
    Number of Hemoglobin Measured by Blood Test
    Time Frame
    5 days after surgery
    Title
    Red Blood Cell
    Description
    Number of Red Blood Cell Measured by Complete Blood Count
    Time Frame
    1 day before surgery
    Title
    Red Blood Cell
    Description
    Number of Red Blood Cell Measured by Complete Blood Count
    Time Frame
    1 day after surgery
    Title
    Red Blood Cell
    Description
    Number of Red Blood Cell Measured by Complete Blood Count
    Time Frame
    3 days after surgery
    Title
    Red Blood Cell
    Description
    Number of Red Blood Cell Measured by Complete Blood Count
    Time Frame
    5 days after surgery
    Title
    Volume of Transfusion
    Description
    Volume of Blood Transfusion
    Time Frame
    During Hospitalization
    Title
    Transfusion Rate
    Description
    Number of patients who receive transfusion divided by total number of patients in the group
    Time Frame
    During Hospitalization
    Title
    Superficial Infection
    Description
    Number of patients who suffer superficial infection
    Time Frame
    During Hospitalization
    Title
    Superficial Infection
    Description
    Number of patients who suffer superficial infection
    Time Frame
    1 month after surgery
    Title
    Superficial Infection
    Description
    Number of patients who suffer superficial infection
    Time Frame
    3 months after surgery
    Title
    Superficial Infection
    Description
    Number of patients who suffer superficial infection
    Time Frame
    6 months after surgery
    Title
    Deep Infection
    Description
    Number of patients who suffer deep infection
    Time Frame
    During Hospitalization
    Title
    Deep Infection
    Description
    Number of patients who suffer deep infection
    Time Frame
    1 month after surgery
    Title
    Deep Infection
    Description
    Number of patients who suffer deep infection
    Time Frame
    3 months after surgery
    Title
    Deep Infection
    Description
    Number of patients who suffer deep infection
    Time Frame
    6 months after surgery
    Title
    Ecchymosis incidence Rate
    Description
    Number of patients who suffer ecchymosis divided by total number of patients in the group
    Time Frame
    1 month after surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Selective Thromboembolism Prophylaxis After Arthroplasty

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