Chronic Kidney Diseases Receiving AnticoagulantsNCT06543927
Frequency and Risk Factors of Bleeding in Patients With Chronic Kidney Disease Receiving Anticoagulants
An observational study of Chronic Kidney Diseases Receiving Anticoagulants, run by Sohag University at 1 site in Egypt.
Trial summary
1-Introduction: Chronic kidney disease (CKD) is a significant global public health issue, closely linked to cardiovascular disease (CVD). Moreover, CKD is acknowledged as an independent risk factor for developing CVD and represents a heigh risk factor to thromboembolic disease in coronary and cerebral arteries also in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Diseases Receiving Anticoagulants
- What is being tested?
- serum creatinine and INR
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Feb 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: • Patients with CKD who required and are currently receiving anticoagulation therapy according to the last guidelines, like: Patient was diagnosed with acute DVT, and or pulmonary embolism, and or splanchnic venous thrombosis. Mechanical heart valve, Prevention of stroke and systemic embolism in nonvalvular AF with at least one stroke risk factor : * Prior stroke (ischaemic or unknown type), transient ischaemic attack (TIA) or non-central nervous system (CNS) systemic embolism. * Age ≥ 75 years. * Hypertension. iv. Diabetes mellitus. * Heart failure and/ or left ventricular EF ≤ 35%. * Patients with CKD ( maintenance or not on hemodialysis) * Willing and agreed to be included in the study.
Who may be able to join
- • Patients with CKD who required and are currently receiving anticoagulation therapy according to the last guidelines, like: Patient was diagnosed with acute DVT, and or pulmonary embolism, and or splanchnic venous thrombosis.
- Mechanical heart valve,
- Prevention of stroke and systemic embolism in nonvalvular AF with at least one stroke risk factor :
- Prior stroke (ischaemic or unknown type), transient ischaemic attack (TIA) or non-central nervous system (CNS) systemic embolism.
- Age ≥ 75 years.
- Hypertension. iv. Diabetes mellitus.
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- Heart failure and/ or left ventricular EF ≤ 35%.
- Patients with CKD ( maintenance or not on hemodialysis)
- Willing and agreed to be included in the study
Who cannot join
- • Significant inherited or acquired bleeding disorder
- Patient with family history of bleeding tendency
- Patient with contraindication to use anticoagulants
- Clinically significant active bleeding
- Hepatic disease with associated coagulopathy including Child-Pugh C
- Lesions or conditions at significant risk of bleeding including intracranial hemorrhage unless under the advice of a neurologist/neurosurgeon
- Pregnancy, and lactating patient or suspected of pregnancy,
- Incapable of consenting
Trial locations and contacts
1 site in 1 country.
sharaf S Abd Allah, professor contact
About this study
Official title: Frequncy and Risk Factors of Bleeding in Patients With Chronic Kidney Disease Receiving Antigoagulants
1-Introduction: Chronic kidney disease (CKD) is a significant global public health issue, closely linked to cardiovascular disease (CVD). Moreover, CKD is acknowledged as an independent risk factor for developing CVD and represents a heigh risk factor to thromboembolic disease in coronary and cerebral arteries also in the venous circulation that requires anticoagulation (1). According to the latest United States Renal Data System report, the prevalence of any CVD in CKD patients is nearly double that of the general population, at 69.8% compared to 34.8% (2). Also, if microalbuminuria is detected and glomerular filtration rate (eGFR) is less than <60 mL/min/1.73m2, there is an increased risk of cardiovascular events, venous thrombosis and mortality (3).
On the other hand, patients with an eGFR of less than 60 mL/min/1.73m² have double the risk of atrial fibrillation (AF) and acute coronary syndrome (ACS) (4\&5). For dialysis-dependent CKD patients, the prevalence of AF is 11.6%, and within 12 months after kidney transplantation, the risk of AF occurrence rises to 35.6% per 1000 patient-years (6). Also, the risk of pulmonary venous thromboembolism (VTE) in CKD increases by 25%-30% is constant in all CKD stages, and typically characterizes the nephrotic syndrome (7).
Read more
Oral anticoagulant is an effective mean of reducing rate of ischemic stroke and systemic embolism in patient with AF in CKD patient and minimizing the morbidity and the mortality caused by venous thromboembolic disease (1). At the same time abnormalities in the platelet membrane and impaired platelet-vessel wall interaction put CKD patients at risk of bleeding significantly more than other patients of chronic disease (8).
The paradox in CKD is the association between the high thromboembolic risk and major hemorrhagic risk with declining kidney function. In CKD, managing the delicate balance between preventing thromboembolic events and avoiding hemorrhage poses significant challenges for anticoagulation treatment. This difficulty arises due to several factors:
- A higher need for anticoagulants in CKD patients.
- The absence of reliable risk scores for thromboembolic and hemorrhagic events specific to CKD patients.
- The risk-benefit ratio being influenced by numerous variables unique to this subgroup.
- Drugs bioavailability and pharmacokinetics are altered in this setting.
- A lack of consensus on recommendations for oral anticoagulation, particularly for patients in stages 4 and 5 of CKD (1).
- Randomized trials comparing direct oral anticoagulants (DOACs) and warfarin have excluded patients with creatinine clearance (CrCl) below 30 mL/min. Lack of high-quality evidence in CKD has led to differences in recommendations by various professional bodies adding on to this confusion (9). This has thus led to underutilization of DOACs in CKD patients (10) .
Due to the currently limited data, clinicians need practical clues for monitoring and optimizing the anticoagulant therapy. We try to explain the complex thrombotic-hemorrhagic state of CKD patients, and practical considerations for the management of anticoagulation in them with a focus on risk factors for bleeding.
- Being tested
- serum creatinine, INR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum creatinineDiagnostic test
Detection of renal impairment in patients receiving anticoagulants
INRDiagnostic test
Detection of bleeding in patients with choronic kidney disease receiving anticoagulants
| Study group | Role | What they receive |
|---|---|---|
| group A | hemodialysis dependant Receives: Diagnostic Test: serum creatinine; Diagnostic Test: INR | |
| group B | hemodialysis non dependant Receives: Diagnostic Test: serum creatinine; Diagnostic Test: INR |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of bleeding in patients with choronic kidney disease receiving anticoagulants
frequency and risk factors of bleeding in patients with choronic kidney disease receiving anticoagulants
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Diseases Receiving AnticoagulantsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Abozaid, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543927
- Sponsor's protocol ID
- Soh-Med-24-07-02MS
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hughes S, Szeki I, Nash MJ, Thachil J. Anticoagulation in chronic kidney disease patients-the practical aspects. Clin Kidney J. 2014 Oct;7(5):442-9. doi: 10.1093/ckj/sfu080. Epub 2014 Aug 2.
PubMed 25878775Said S, Hernandez GT. The link between chronic kidney disease and cardiovascular disease. J Nephropathol. 2014 Jul;3(3):99-104. doi: 10.12860/jnp.2014.19. Epub 2014 Jul 1.
PubMed 25093157Lau YC, Proietti M, Guiducci E, Blann AD, Lip GYH. Atrial Fibrillation and Thromboembolism in Patients With Chronic Kidney Disease. J Am Coll Cardiol. 2016 Sep 27;68(13):1452-1464. doi: 10.1016/j.jacc.2016.06.057.
PubMed 27659468Liao JN, Chao TF, Liu CJ, Wang KL, Chen SJ, Lin YJ, Chang SL, Lo LW, Hu YF, Tuan TC, Chung FP, Chen TJ, Chen SA. Incidence and risk factors for new-onset atrial fibrillation among patients with end-stage renal disease undergoing renal replacement therapy. Kidney Int. 2015 Jun;87(6):1209-15. doi: 10.1038/ki.2014.393. Epub 2015 Jan 14.
PubMed 25587708
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequncy and Risk Factors of Bleeding in Patients With Chronic Kidney Disease Receiving Antigoagulants
- ClinicalTrials.gov ID
- NCT06543927
- Acronym / sponsor ID
- Soh-Med-24-07-02MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 9 Aug 2024 (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.
1-Introduction: Chronic kidney disease (CKD) is a significant global public health issue, closely linked to cardiovascular disease (CVD). Moreover, CKD is acknowledged as an independent risk factor for developing CVD and represents a heigh risk factor to thromboembolic disease in coronary and cerebral arteries also in the venous circulation that requires anticoagulation (1). According to the latest United States Renal Data System report, the prevalence of any CVD in CKD patients is nearly double that of the general population, at 69.8% compared to 34.8% (2). Also, if microalbuminuria is detected and glomerular filtration rate (eGFR) is less than <60 mL/min/1.73m2, there is an increased risk of cardiovascular events, venous thrombosis and mortality (3).
On the other hand, patients with an eGFR of less than 60 mL/min/1.73m² have double the risk of atrial fibrillation (AF) and acute coronary syndrome (ACS) (4\&5). For dialysis-dependent CKD patients, the prevalence of AF is 11.6%, and within 12 months after kidney transplantation, the risk of AF occurrence rises to 35.6% per 1000 patient-years (6). Also, the risk of pulmonary venous thromboembolism (VTE) in CKD increases by 25%-30% is constant in all CKD stages, and typically characterizes the nephrotic syndrome (7).
Oral anticoagulant is an effective mean of reducing rate of ischemic stroke and systemic embolism in patient with AF in CKD patient and minimizing the morbidity and the mortality caused by venous thromboembolic disease (1). At the same time abnormalities in the platelet membrane and impaired platelet-vessel wall interaction put CKD patients at risk of bleeding significantly more than other patients of chronic disease (8).
The paradox in CKD is the association between the high thromboembolic risk and major hemorrhagic risk with declining kidney function. In CKD, managing the delicate balance between preventing thromboembolic events and avoiding hemorrhage poses significant challenges for anticoagulation treatment. This difficulty arises due to several factors:
- A higher need for anticoagulants in CKD patients.
- The absence of reliable risk scores for thromboembolic and hemorrhagic events specific to CKD patients.
- The risk-benefit ratio being influenced by numerous variables unique to this subgroup.
- Drugs bioavailability and pharmacokinetics are altered in this setting.
- A lack of consensus on recommendations for oral anticoagulation, particularly for patients in stages 4 and 5 of CKD (1).
- Randomized trials comparing direct oral anticoagulants (DOACs) and warfarin have excluded patients with creatinine clearance (CrCl) below 30 mL/min. Lack of high-quality evidence in CKD has led to differences in recommendations by various professional bodies adding on to this confusion (9). This has thus led to underutilization of DOACs in CKD patients (10) .
Due to the currently limited data, clinicians need practical clues for monitoring and optimizing the anticoagulant therapy. We try to explain the complex thrombotic-hemorrhagic state of CKD patients, and practical considerations for the management of anticoagulation in them with a focus on risk factors for bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Diagnostic Test: serum creatinine, Diagnostic Test: INRhemodialysis dependant |
| group B | – | Diagnostic Test: serum creatinine, Diagnostic Test: INRhemodialysis non dependant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- • Patients with CKD who required and are currently receiving anticoagulation therapy according to the last guidelines, like: Patient was diagnosed with acute DVT, and or pulmonary embolism, and or splanchnic venous thrombosis. Mechanical heart valve, Prevention of stroke and systemic embolism in nonvalvular AF with at least one stroke risk factor : * Prior stroke (ischaemic or unknown type), transient ischaemic attack (TIA) or non-central nervous system (CNS) systemic embolism. * Age ≥ 75 years. * Hypertension. iv. Diabetes mellitus. * Heart failure and/ or left ventricular EF ≤ 35%. * Patients with CKD ( maintenance or not on hemodialysis) * Willing and agreed to be included in the study.
Key inclusion criteria (9 listed)
- • Patients with CKD who required and are currently receiving anticoagulation therapy according to the last guidelines, like: Patient was diagnosed with acute DVT, and or pulmonary embolism, and or splanchnic venous thrombosis.
- Mechanical heart valve,
- Prevention of stroke and systemic embolism in nonvalvular AF with at least one stroke risk factor :
- Prior stroke (ischaemic or unknown type), transient ischaemic attack (TIA) or non-central nervous system (CNS) systemic embolism.
- Age ≥ 75 years.
Key exclusion criteria (8 listed)
- • Significant inherited or acquired bleeding disorder
- Clinically significant active bleeding
- Hepatic disease with associated coagulopathy including Child-Pugh C
- Lesions or conditions at significant risk of bleeding including intracranial hemorrhage unless under the advice of a neurologist/neurosurgeon
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 |
|---|---|---|
| serum creatinineDetection of renal impairment in patients receiving anticoagulants | Diagnostic test | group A, group B |
| INRDetection of bleeding in patients with choronic kidney disease receiving anticoagulants | Diagnostic test | group A, group B |
Primary outcome
frequency of bleeding in patients with choronic kidney disease receiving anticoagulants
Time frame: 6 months
frequency and risk factors of bleeding in patients with choronic kidney disease receiving anticoagulants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 25878775Hughes S, Szeki I, Nash MJ, Thachil J. Anticoagulation in chronic kidney disease patients-the practical aspects. Clin Kidney J. 2014 Oct;7(5):442-9. doi: 10.1093/ckj/sfu080. Epub 2014 Aug 2.
- Background: PubMed 25093157Said S, Hernandez GT. The link between chronic kidney disease and cardiovascular disease. J Nephropathol. 2014 Jul;3(3):99-104. doi: 10.12860/jnp.2014.19. Epub 2014 Jul 1.
- Background: PubMed 27659468Lau YC, Proietti M, Guiducci E, Blann AD, Lip GYH. Atrial Fibrillation and Thromboembolism in Patients With Chronic Kidney Disease. J Am Coll Cardiol. 2016 Sep 27;68(13):1452-1464. doi: 10.1016/j.jacc.2016.06.057.
- Background: PubMed 25587708Liao JN, Chao TF, Liu CJ, Wang KL, Chen SJ, Lin YJ, Chang SL, Lo LW, Hu YF, Tuan TC, Chung FP, Chen TJ, Chen SA. Incidence and risk factors for new-onset atrial fibrillation among patients with end-stage renal disease undergoing renal replacement therapy. Kidney Int. 2015 Jun;87(6):1209-15. doi: 10.1038/ki.2014.393. Epub 2015 Jan 14.
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.
sharaf S Abd Allah, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases Receiving Anticoagulants, run by Sohag University at 1 site in Egypt.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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 Egypt. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed M Mohammed, resident (01126675531, mohamed_mahmoud_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of bleeding in patients with choronic kidney disease receiving anticoagulants (time frame: 6 months). 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 NCT06543927, which also lists 4 linked publications.
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 9 Aug 2024.