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Venous Thrombosis, DeepNCT03804697

Selective Thromboembolism Prophylaxis After Arthroplasty

A study testing selective anticoagulation in people with Venous Thrombosis, Deep and Arthroplasty Complications, run by Guangdong Provincial People's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
selective anticoagulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
No sites listed yet
Study dates
1 Aug 2016to 1 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
selective anticoagulation
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • selective anticoagulationDrug

    Also called Thromboelastography

    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.

Study groups in NCT03804697
Study groupRoleWhat they receive
selective anticoagulation groupExperimentalSelective 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.
Receives: Drug: selective anticoagulation
conventional anticoagulation groupActive comparatorThe 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.
Receives: Drug: selective anticoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Incidence of Deep Vein Thrombosis

    Measured by ultrasound,

    Measured: 1 day after surgery

  2. The Incidence of Deep Vein Thrombosis

    Measured by ultrasound

    Measured: 3 days after surgery

  3. The Incidence of Deep Vein Thrombosis

    Measured by ultrasound

    Measured: 5 days after surgery

  4. The Incidence of Deep Vein Thrombosis

    Measured by ultrasound

    Measured: 1 month after surgery

  5. The Incidence of Deep Vein Thrombosis

    Measured by ultrasound

    Measured: 3 months after surgery

  6. The Incidence of Deep Vein Thrombosis

    Measured by ultrasound

    Measured: 6 months after surgery

Secondary outcomes (23)

  1. Hematocrit

    Measured by Complete Blood Count

    Measured: 1 day before surgery

  2. Hematocrit

    Measured by Complete Blood Count

    Measured: 1 day after surgery

  3. Hematocrit

    Measured by Complete Blood Count

    Measured: 3 days after surgery

  4. Hematocrit

    Measured by Complete Blood Count

    Measured: 5 days after surgery

  5. Hemoglobin

    Number of Hemoglobin Measured by Blood Test

    Measured: 1 day before surgery

  6. Hemoglobin

    Number of Hemoglobin Measured by Blood Test

    Measured: 1 day after surgery

  7. Hemoglobin

    Number of Hemoglobin Measured by Blood Test

    Measured: 3 days after surgery

  8. Hemoglobin

    Number of Hemoglobin Measured by Blood Test

    Measured: 5 days after surgery

  9. Red Blood Cell

    Number of Red Blood Cell Measured by Complete Blood Count

    Measured: 1 day before surgery

  10. Red Blood Cell

    Number of Red Blood Cell Measured by Complete Blood Count

    Measured: 1 day after surgery

  11. Red Blood Cell

    Number of Red Blood Cell Measured by Complete Blood Count

    Measured: 3 days after surgery

  12. Red Blood Cell

    Number of Red Blood Cell Measured by Complete Blood Count

    Measured: 5 days after surgery

  13. Volume of Transfusion

    Volume of Blood Transfusion

    Measured: During Hospitalization

  14. Transfusion Rate

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

    Measured: During Hospitalization

  15. Superficial Infection

    Number of patients who suffer superficial infection

    Measured: During Hospitalization

  16. Superficial Infection

    Number of patients who suffer superficial infection

    Measured: 1 month after surgery

  17. Superficial Infection

    Number of patients who suffer superficial infection

    Measured: 3 months after surgery

  18. Superficial Infection

    Number of patients who suffer superficial infection

    Measured: 6 months after surgery

  19. Deep Infection

    Number of patients who suffer deep infection

    Measured: During Hospitalization

  20. Deep Infection

    Number of patients who suffer deep infection

    Measured: 1 month after surgery

  21. Deep Infection

    Number of patients who suffer deep infection

    Measured: 3 months after surgery

  22. Deep Infection

    Number of patients who suffer deep infection

    Measured: 6 months after surgery

  23. Ecchymosis incidence Rate

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

    Measured: 1 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start1 Aug 2016
  3. Primary completion31 Aug 2017
  4. Study completion1 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03804697
Sponsor's protocol ID
2016-46
Status last verified
Dec 2018
First submitted
28 Dec 2018
Last updated
15 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing selective anticoagulation in people with Venous Thrombosis, Deep and Arthroplasty Complications, run by Guangdong Provincial People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Incidence of Deep Vein Thrombosis (time frame: 1 day after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03804697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019; AzTrials last refreshed its copy on 29 Oct 2026.

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