Back to resultsRisk Stratification Procedure for Thromboembolism Prophylaxis
Primary Purpose
Total Knee Replacement Surgeries
Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
acetylsalicylic acid
Sponsored by
About this trial
This is an interventional prevention trial for Total Knee Replacement Surgeries focused on measuring Total Knee Replacement, Venous thromboembolism (VTE), Risk Stratification
Eligibility Criteria
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.
Sites / Locations
- Prince Sultan Medical Military City
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A
Group B
Arm Description
In this group a VTE risk stratification procedure will be used
In this group a standard VTE risk stratification procedure will be used (Caprini VTE risk assessment tool)
Outcomes
Primary Outcome Measures
Venous thromboembolism (VTE) complications
Deep vein thrombosis, pulmonary embolism, sudden death
Bleeding events
Major or minor bleeding will be recorded
Secondary Outcome Measures
Surgical site infection
Surgical site infection post operation
Full Information
NCT ID
NCT04031859
First Posted
July 22, 2019
Last Updated
February 23, 2020
Sponsor
Ministry of Health, Saudi Arabia
Collaborators
Prince Sultan Military College of Health Sciences, Universiti Sains Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT04031859
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
July 14, 2019 (Actual)
Study Completion Date
July 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Saudi Arabia
Collaborators
Prince Sultan Military College of Health Sciences, Universiti Sains Malaysia
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Replacement Surgeries
Keywords
Total Knee Replacement, Venous thromboembolism (VTE), Risk Stratification
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
In this group a VTE risk stratification procedure will be used
Arm Title
Group B
Arm Type
No Intervention
Arm Description
In this group a standard VTE risk stratification procedure will be used (Caprini VTE risk assessment tool)
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid
Other Intervention Name(s)
VTE risk stratification procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Venous thromboembolism (VTE) complications
Description
Deep vein thrombosis, pulmonary embolism, sudden death
Time Frame
35 days post total Knee Replacement surgery
Title
Bleeding events
Description
Major or minor bleeding will be recorded
Time Frame
35 days post total Knee Replacement surgery
Secondary Outcome Measure Information:
Title
Surgical site infection
Description
Surgical site infection post operation
Time Frame
35 days post total Knee Replacement surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Alameri, MSC
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince Sultan Medical Military City
City
Riyadh
ZIP/Postal Code
00966
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33029262
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.
Results Reference
derived
Learn more about this trial
Risk Stratification Procedure for Thromboembolism Prophylaxis
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