NCT04031859

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

July 22, 2019

Last Update Submit

February 23, 2020

Conditions

Total Knee Replacement Surgeries

Keywords

Total Knee ReplacementVenous thromboembolism (VTE)Risk Stratification

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Surgical site infection

    35 days post total Knee Replacement surgery

Study Arms (2)

Group A

EXPERIMENTAL

In this group a VTE risk stratification procedure will be used

Drug: acetylsalicylic acid

Group B

NO INTERVENTION

In this group a standard VTE risk stratification procedure will be used (Caprini VTE risk assessment tool)

Interventions

acetylsalicylic acidDRUG

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.

Also known as: VTE risk stratification procedure
Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sultan Medical Military City

Riyadh, 00966, Saudi Arabia

Location

Related Publications (1)

  • Alameri MA, Syed Sulaiman SA, Ashour AM, Al-Saati MF. Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial. Pharm Pract (Granada). 2020 Jul-Sep;18(3):2025. doi: 10.18549/PharmPract.2020.3.2025. Epub 2020 Sep 22.

    PMID: 33029262DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Aspirin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Mariam Alameri, MSC

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 24, 2019

Study Start

October 10, 2018

Primary Completion

July 14, 2019

Study Completion

July 22, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)