NCT04031859

Risk Stratification Procedure for Thromboembolism Prophylaxis

The Effectiveness of a Risk Stratification Procedure for Thromboembolism Prophylaxis After Total Knee Replacement Surgeries

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Ministry of Health, Saudi Arabia · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective for this study is validation for the proposed risk stratification tool, by evaluating the clinical outcomes for its use post TKR Surgeries. For this objective, the design that is used is Randomized Trial.

Detailed description

All patients that will have total knee replacement, in a given period of time in both medical centers; Prince Sultan Military Medical City (PSMMC) and King Abd Allah University Hospital (KAAUH) in Princess Noura University, will be randomly separated into 2 groups; in the first group (A): Venous thromboembolism (VTE) risk stratification tool (which is prepared by a clinical pharmacist) will be applied to choose the tailored extended VTE prophylactic agent. While in the second group (B), the risk stratification tool will not be used, rather it will follow the routine hospital protocol for choosing the VTE prophylactic agent, which is Caprini: a standard validated model. Then each group of patients will be followed till 35 days post-operation, during which all VTE or bleeding events should be recorded.

Conditions

• Total Knee Replacement Surgeries

Interventions

Type	Name	Description
DRUG	acetylsalicylic acid	It's a VTE risk stratification tool or procedure that will be used after total knee replacement (TKR) to help surgeons in choosing the tailored VTE prophylaxis according to patients' specific VTE risk, this tool will stratify the TKR-patient in one of three risk-groups: Low high risk who will be prescribed Aspirin upon hospital discharge as extended VTE prophylaxis post TKR surgery, or moderate high risk group who will be prescribed oral anti coagulant (like rivaroxaban) as extended prophylaxis, and the last group is very high risk group who will be prescribed parenteral anticoagulant ( like Enoxaparin) plus compression devices.

Timeline

• Start date: 2018-10-10
• Primary completion: 2019-07-14
• Completion: 2019-07-22
• First posted: 2019-07-24
• Last updated: 2020-02-25

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study