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Completed

NCT Number: NCT04031859

Risk Stratification Procedure for Thromboembolism Prophylaxis

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.

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Key information

Conditions

Total Knee Replacement Surgeries Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prince Sultan Medical Military City

Riyadh, 00966, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetylsalicylic acid

Drug

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

Primary outcomes

  1. Venous thromboembolism (VTE) complications

    Time frame: 35 days post total Knee Replacement surgery

    Deep vein thrombosis, pulmonary embolism, sudden death

  2. Bleeding events

    Time frame: 35 days post total Knee Replacement surgery

    Major or minor bleeding will be recorded

Secondary outcomes

  1. Surgical site infection

    Time frame: 35 days post total Knee Replacement surgery

    Surgical site infection post operation

Sponsors and collaborators

Lead sponsor

Ministry of Health, Saudi Arabia

Other Gov

Collaborators

  • Prince Sultan Military College of Health Sciences
  • Universiti Sains Malaysia

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2019
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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