Risk Stratification Procedure for Thromboembolism Prophylaxis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Total Knee Replacement Surgeries

Intervention / Treatment
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* Drug: acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female patients who are planned for elective TKR surgery (primary only). Agreed to sign the Informed consent form (ICF). Patients aged older than 18 years. Exclusion Criteria: Patients receiving anticoagulant for treatment. Patients with a history of DVT or PE were excluded from the study due to the marked increase in the risk of recurrent VTE compared to the general risk of (7% vs. 0.1%); (Fahrni, 2015). Patients with renal or hepatic failure, renal failure is defined as end-stage kidney disease (on dialysis); hepatic failure is defined as complete liver cirrhosis. Pregnant woman. Revision surgeries.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>In this group a VTE risk stratification procedure will be used | Drug: acetylsalicylic acid<br>* 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.<br>* Other names: VTE risk stratification procedure;|
| No Intervention: Group B<br>In this group a standard VTE risk stratification procedure will be used (Caprini VTE risk assessment tool) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism (VTE) complications | Deep vein thrombosis, pulmonary embolism, sudden death | 35 days post total Knee Replacement surgery | 
| Bleeding events | Major or minor bleeding will be recorded | 35 days post total Knee Replacement surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Surgical site infection post operation | 35 days post total Knee Replacement surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Venous thromboembolism (VTE), Risk Stratification