Total Knee Replacement SurgeriesPhase 2NCT04031859
Risk Stratification Procedure for Thromboembolism Prophylaxis
A Phase 2 study testing acetylsalicylic acid in people with Total Knee Replacement Surgeries, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement Surgeries
- What is being tested?
- acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Oct 2018to 22 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Risk Stratification Procedure for Thromboembolism Prophylaxis After Total Knee Replacement Surgeries
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.
Read the 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.
- Conditions
- Total Knee Replacement Surgeries
- Being tested
- acetylsalicylic acid
- Keywords
- Total Knee Replacement, Venous thromboembolism (VTE), Risk Stratification
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acidDrug
Also called VTE risk stratification procedure
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | In this group a VTE risk stratification procedure will be used Receives: Drug: acetylsalicylic acid |
| Group B | No intervention | In this group a standard VTE risk stratification procedure will be used (Caprini VTE risk assessment tool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism (VTE) complications
Deep vein thrombosis, pulmonary embolism, sudden death
Measured: 35 days post total Knee Replacement surgery
Bleeding events
Major or minor bleeding will be recorded
Measured: 35 days post total Knee Replacement surgery
Secondary outcomes (1)
Surgical site infection
Surgical site infection post operation
Measured: 35 days post total Knee Replacement surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start10 Oct 2018
- Primary completion14 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee Replacement SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Collaborators
- Prince Sultan Military College of Health Sciences, Universiti Sains Malaysia
- Responsible party
- Principal investigator, Mariam Ahmad Alameri, Clinical Pharmacist, Ministry of Health, Saudi Arabia
- Investigators
- Mariam Alameri, MSC, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031859
- Sponsor's protocol ID
- PSMMC & KAAUH
- Status last verified
- Feb 2020
- First submitted
- 22 Jul 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33029262
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Risk Stratification Procedure for Thromboembolism Prophylaxis After Total Knee Replacement Surgeries
- ClinicalTrials.gov ID
- NCT04031859
- Acronym / sponsor ID
- PSMMC & KAAUH
- Conditions
- Total Knee Replacement Surgeries
- Keywords
- Total Knee Replacement, Venous thromboembolism (VTE), Risk Stratification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Collaborators
- Prince Sultan Military College of Health Sciences, Universiti Sains Malaysia
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 14 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: acetylsalicylic acidIn this group a VTE risk stratification procedure will be used |
| Group B | No intervention | –In this group a standard VTE risk stratification procedure will be used (Caprini VTE risk assessment tool) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicylic acidAlso: VTE risk stratification procedureIt'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. | Drug | Group A |
Primary outcome
Venous thromboembolism (VTE) complications
Time frame: 35 days post total Knee Replacement surgery
Deep vein thrombosis, pulmonary embolism, sudden death
Bleeding events
Time frame: 35 days post total Knee Replacement surgery
Major or minor bleeding will be recorded
1 secondary outcome
Surgical site infection
Time frame: 35 days post total Knee Replacement surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 33029262Alameri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariam Alameri, MSC principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acetylsalicylic acid in people with Total Knee Replacement Surgeries, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism (VTE) complications (time frame: 35 days post total Knee Replacement surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.