Selective Thromboembolism Prophylaxis After Arthroplasty

January 13, 2019 updated by: Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: selective anticoagulation group

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.
Drug: selective anticoagulation
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
ACTIVE_COMPARATOR: conventional anticoagulation group

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.
Drug: selective anticoagulation
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Incidence of Deep Vein Thrombosis
Time Frame: 1 day after surgery
Measured by ultrasound,
1 day after surgery
The Incidence of Deep Vein Thrombosis
Time Frame: 3 days after surgery
Measured by ultrasound
3 days after surgery
The Incidence of Deep Vein Thrombosis
Time Frame: 5 days after surgery
Measured by ultrasound
5 days after surgery
The Incidence of Deep Vein Thrombosis
Time Frame: 1 month after surgery
Measured by ultrasound
1 month after surgery
The Incidence of Deep Vein Thrombosis
Time Frame: 3 months after surgery
Measured by ultrasound
3 months after surgery
The Incidence of Deep Vein Thrombosis
Time Frame: 6 months after surgery
Measured by ultrasound
6 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hematocrit
Time Frame: 1 day before surgery
Measured by Complete Blood Count
1 day before surgery
Hematocrit
Time Frame: 1 day after surgery
Measured by Complete Blood Count
1 day after surgery
Hematocrit
Time Frame: 3 days after surgery
Measured by Complete Blood Count
3 days after surgery
Hematocrit
Time Frame: 5 days after surgery
Measured by Complete Blood Count
5 days after surgery
Hemoglobin
Time Frame: 1 day before surgery
Number of Hemoglobin Measured by Blood Test
1 day before surgery
Hemoglobin
Time Frame: 1 day after surgery
Number of Hemoglobin Measured by Blood Test
1 day after surgery
Hemoglobin
Time Frame: 3 days after surgery
Number of Hemoglobin Measured by Blood Test
3 days after surgery
Hemoglobin
Time Frame: 5 days after surgery
Number of Hemoglobin Measured by Blood Test
5 days after surgery
Red Blood Cell
Time Frame: 1 day before surgery
Number of Red Blood Cell Measured by Complete Blood Count
1 day before surgery
Red Blood Cell
Time Frame: 1 day after surgery
Number of Red Blood Cell Measured by Complete Blood Count
1 day after surgery
Red Blood Cell
Time Frame: 3 days after surgery
Number of Red Blood Cell Measured by Complete Blood Count
3 days after surgery
Red Blood Cell
Time Frame: 5 days after surgery
Number of Red Blood Cell Measured by Complete Blood Count
5 days after surgery
Volume of Transfusion
Time Frame: During Hospitalization
Volume of Blood Transfusion
During Hospitalization
Transfusion Rate
Time Frame: During Hospitalization
Number of patients who receive transfusion divided by total number of patients in the group
During Hospitalization
Superficial Infection
Time Frame: During Hospitalization
Number of patients who suffer superficial infection
During Hospitalization
Superficial Infection
Time Frame: 1 month after surgery
Number of patients who suffer superficial infection
1 month after surgery
Superficial Infection
Time Frame: 3 months after surgery
Number of patients who suffer superficial infection
3 months after surgery
Superficial Infection
Time Frame: 6 months after surgery
Number of patients who suffer superficial infection
6 months after surgery
Deep Infection
Time Frame: During Hospitalization
Number of patients who suffer deep infection
During Hospitalization
Deep Infection
Time Frame: 1 month after surgery
Number of patients who suffer deep infection
1 month after surgery
Deep Infection
Time Frame: 3 months after surgery
Number of patients who suffer deep infection
3 months after surgery
Deep Infection
Time Frame: 6 months after surgery
Number of patients who suffer deep infection
6 months after surgery
Ecchymosis incidence Rate
Time Frame: 1 month after surgery
Number of patients who suffer ecchymosis divided by total number of patients in the group
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-46 (OTHER: Assistance Publique-Hôpitaux de Marseille)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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