Clinical trial NCT04031859: Risk Stratification Procedure for Thromboembolism Prophylaxis
Official title: The Effectiveness of a Risk Stratification Procedure for Thromboembolism Prophylaxis After Total Knee Replacement Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Total Knee Replacement Surgeries
Keywords: Total Knee Replacement
Venous thromboembolism (VTE)
Risk Stratification
Lead sponsor: Ministry of Health, Saudi Arabia
Sponsor class: OTHER_GOV
Collaborators: name: Prince Sultan Military College of Health Sciences
name: Universiti Sains Malaysia
First posted: 2019-07-24
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Venous thromboembolism (VTE) complications
timeFrame: 35 days post total Knee Replacement surgery
measure: Bleeding events
timeFrame: 35 days post total Knee Replacement surgery
Secondary outcomes:
measure: Surgical site infection
timeFrame: 35 days post total Knee Replacement surgery
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Medical Military City
Study officials:
affiliation: Universiti Sains Malaysia
name: Mariam Alameri, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.