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Risk Stratification Procedure for Thromboembolism Prophylaxis

NCT04031859 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2020-02-25

No results posted yet for this study

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.

Conditions

  • Total Knee Replacement Surgeries

Interventions

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.

Sponsors & Collaborators

  • Prince Sultan Military College of Health Sciences

    collaborator OTHER

  • Universiti Sains Malaysia

    collaborator OTHER

  • Ministry of Health, Saudi Arabia

    lead OTHER_GOV

Principal Investigators

  • Mariam Alameri, MSC · Universiti Sains Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2019-07-14
Completion
2019-07-22
FDA Drug
Yes

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031859 on ClinicalTrials.gov