Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543927
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Frequency and Risk Factors of Bleeding in Patients With Chronic Kidney Disease Receiving Anticoagulants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Frequncy and Risk Factors of Bleeding in Patients With Chronic Kidney Disease Receiving Antigoagulants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 698 compared to 348 2 Also if microalbuminuria is detected and glomerular filtration rate eGFR is less than 60 mLmin173m2 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 mLmin173m² have double the risk of atrial fibrillation AF and acute coronary syndrome ACS 45 For dialysis-dependent CKD patients the prevalence of AF is 116 and within 12 months after kidney transplantation the risk of AF occurrence rises to 356 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 mLmin 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
On the other hand patients with an eGFR of less than 60 mLmin173m² have double the risk of atrial fibrillation AF and acute coronary syndrome ACS 45 For dialysis-dependent CKD patients the prevalence of AF is 116 and within 12 months after kidney transplantation the risk of AF occurrence rises to 356 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 mLmin 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None