Risk Stratification Procedure for Thromboembolism Prophylaxis

Total Knee Replacement Surgeries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031859
• Other study ID #: PSMMC & KAAUH
• Status: Completed
• Phase: Phase 2
• Start date: October 10, 2018
• Est. completion date: July 22, 2019

Study information

• Verified date: February 2020
• Source: Ministry of Health, Saudi Arabia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: July 22, 2019
• Est. primary completion date: July 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thromboembolism
• Total Knee Replacement Surgeries

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	Prince Sultan Medical Military City	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
Ministry of Health, Saudi Arabia	Prince Sultan Military College of Health Sciences, University of Science Malaysia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolism (VTE) complications	Deep vein thrombosis, pulmonary embolism, sudden death	35 days post total Knee Replacement surgery
Primary	Bleeding events	Major or minor bleeding will be recorded	35 days post total Knee Replacement surgery
Secondary	Surgical site infection	Surgical site infection post operation	35 days post total Knee Replacement surgery