Selective Thromboembolism Prophylaxis After Arthroplasty

NCT03804697 | Completed DMC

• 1 other identifier: 2016-46
• Study Type: interventional
• Target: 197
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Venous Thrombosis, Deep; Arthroplasty Complications

Outcome Measures

Primary Outcomes (6)

• The Incidence of Deep Vein Thrombosis

  Measured by ultrasound,

  1 day after surgery

• The Incidence of Deep Vein Thrombosis

  Measured by ultrasound

  3 days after surgery

• The Incidence of Deep Vein Thrombosis

  Measured by ultrasound

  5 days after surgery

• The Incidence of Deep Vein Thrombosis

  Measured by ultrasound

  1 month after surgery

• The Incidence of Deep Vein Thrombosis

  Measured by ultrasound

  3 months after surgery

• The Incidence of Deep Vein Thrombosis

  Measured by ultrasound

  6 months after surgery

Secondary Outcomes (23)

• Hematocrit

  1 day before surgery

• Hematocrit

  1 day after surgery

• Hematocrit

  3 days after surgery

• Hematocrit

  5 days after surgery

• Hemoglobin

  1 day before surgery

Study Arms (2)

selective anticoagulation group

EXPERIMENTAL

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

conventional anticoagulation group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Thromboelastography

conventional anticoagulation group; selective anticoagulation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 15, 2019
• Study Start: August 1, 2016
• Primary Completion: August 31, 2017
• Study Completion: January 1, 2018
• Last Updated: January 15, 2019

Record last verified: 2018-12