Selective Thromboembolism Prophylaxis After Arthroplasty

Arthroplasty Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804697
• Other study ID #: 2016-46
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: January 1, 2018

Study information

• Verified date: December 2018
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: January 1, 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• over 18 years of age,

• ASA ?-? 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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Thromboembolism
• Thrombosis
• Venous Thrombosis
• Venous Thrombosis, Deep

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence of Deep Vein Thrombosis	Measured by ultrasound,	1 day after surgery
Primary	The Incidence of Deep Vein Thrombosis	Measured by ultrasound	3 days after surgery
Primary	The Incidence of Deep Vein Thrombosis	Measured by ultrasound	5 days after surgery
Primary	The Incidence of Deep Vein Thrombosis	Measured by ultrasound	1 month after surgery
Primary	The Incidence of Deep Vein Thrombosis	Measured by ultrasound	3 months after surgery
Primary	The Incidence of Deep Vein Thrombosis	Measured by ultrasound	6 months after surgery
Secondary	Hematocrit	Measured by Complete Blood Count	1 day before surgery
Secondary	Hematocrit	Measured by Complete Blood Count	1 day after surgery
Secondary	Hematocrit	Measured by Complete Blood Count	3 days after surgery
Secondary	Hematocrit	Measured by Complete Blood Count	5 days after surgery
Secondary	Hemoglobin	Number of Hemoglobin Measured by Blood Test	1 day before surgery
Secondary	Hemoglobin	Number of Hemoglobin Measured by Blood Test	1 day after surgery
Secondary	Hemoglobin	Number of Hemoglobin Measured by Blood Test	3 days after surgery
Secondary	Hemoglobin	Number of Hemoglobin Measured by Blood Test	5 days after surgery
Secondary	Red Blood Cell	Number of Red Blood Cell Measured by Complete Blood Count	1 day before surgery
Secondary	Red Blood Cell	Number of Red Blood Cell Measured by Complete Blood Count	1 day after surgery
Secondary	Red Blood Cell	Number of Red Blood Cell Measured by Complete Blood Count	3 days after surgery
Secondary	Red Blood Cell	Number of Red Blood Cell Measured by Complete Blood Count	5 days after surgery
Secondary	Volume of Transfusion	Volume of Blood Transfusion	During Hospitalization
Secondary	Transfusion Rate	Number of patients who receive transfusion divided by total number of patients in the group	During Hospitalization
Secondary	Superficial Infection	Number of patients who suffer superficial infection	During Hospitalization
Secondary	Superficial Infection	Number of patients who suffer superficial infection	1 month after surgery
Secondary	Superficial Infection	Number of patients who suffer superficial infection	3 months after surgery
Secondary	Superficial Infection	Number of patients who suffer superficial infection	6 months after surgery
Secondary	Deep Infection	Number of patients who suffer deep infection	During Hospitalization
Secondary	Deep Infection	Number of patients who suffer deep infection	1 month after surgery
Secondary	Deep Infection	Number of patients who suffer deep infection	3 months after surgery
Secondary	Deep Infection	Number of patients who suffer deep infection	6 months after surgery
Secondary	Ecchymosis incidence Rate	Number of patients who suffer ecchymosis divided by total number of patients in the group	1 month after surgery