Risk Stratification Procedure for Thromboembolism Prophylaxis

February 23, 2020 updated by: Mariam Ahmad Alameri, Clinical Pharmacist, Ministry of Health, Saudi Arabia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 00966
        • Prince Sultan Medical Military City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or Female patients who are planned for elective TKR surgery (primary only).
  2. Agreed to sign the Informed consent form (ICF).
  3. Patients aged older than 18 years.

Exclusion Criteria:

  1. Patients receiving anticoagulant for treatment.
  2. 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).
  3. 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.
  4. Pregnant woman.
  5. Revision surgeries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
In this group a VTE risk stratification procedure will be used
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.
Other Names:
  • VTE risk stratification procedure
No Intervention: Group B
In this group a standard VTE risk stratification procedure will be used (Caprini VTE risk assessment tool)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous thromboembolism (VTE) complications
Time Frame: 35 days post total Knee Replacement surgery
Deep vein thrombosis, pulmonary embolism, sudden death
35 days post total Knee Replacement surgery
Bleeding events
Time Frame: 35 days post total Knee Replacement surgery
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
Time Frame: 35 days post total Knee Replacement surgery
Surgical site infection post operation
35 days post total Knee Replacement surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Saudi Arabia

Collaborators

Universiti Sains Malaysia
Prince Sultan Military College of Health Sciences

Investigators

  • Principal Investigator: Mariam Alameri, MSC, Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Actual)

July 14, 2019

Study Completion (Actual)

July 22, 2019

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 23, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSMMC & KAAUH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Total Knee Replacement Surgeries

Clinical Trials on acetylsalicylic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe