Erythropoietin Adverse Reaction Clinical Trial
— EPOASAOfficial title:
The Effect of Low-dose Salicylate Treatment on Platelet Function in Patients With Renal Failure Treated With Darbepoetin Alfa
The aim of the study is to 1. To determine whether treatment with Erythropoiesis-stimulating agents (in the form of Aranesp®) affects platelet function, and how. 2. To determine whether salicylate treatment changes the effect of EPO (erythropoietin) on platelet function.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Chronic hemodialysis, peritoneal dialysis or CKD 5 treated conservatively - aged 18-85 - indication for treatment with Erythropoiesis-stimulating agents (ESA) Exclusion Criteria: 1. Known allergy to ASA 2. Known contraindication to ASA, e.g. recent bleeding episode. 3. Known indication for ASA. If the patient is being treated with ASA, and the physician does not find any indication for this treatment, this can be stopped, and the patient included after 4 weeks. 4. Raised reticulocyte count 5. Current anticoagulant therapy, e.g. warfarin, ADP receptor inhibitor (excepting short-term anticoagulant therapy in connection with dialysis) 6. Short expected length of life 7. Inability to give informed consent 8. Expected non-compliance 9. Active cancer - except for non-melanoma skin-cancer 10. Iron deficiency (defined as a reticulocyte Hgb <1,8 fmol. Patients can be included when their iron deficiency has been cured. . 11. Change in ESA dosis >33,3% within previous 2 month 12. Fertile women. Pregnancy is excessively rare in dialysis patients. Women who are <50 years, or who are still menstruating will be excluded from the study. 13. Stable Aranesp ® dose <20 µg/week. |
Country | Name | City | State |
---|---|---|---|
Denmark | Medicinsk afdeling, SUH Roskilde | Roskilde |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Thrombocytaggregometry | Multiplate induced with arachidonic acid, ADP (adenosine diphosphate) and TRAP (Thrombin receptor-activating peptid) | 16 weeks | |
Secondary | D-dimer | D-dimer, (FEU mg/L) | 16 weeks | |
Secondary | MPV | Mean platelet volume, (fL=femtoliters) | 16 weeks | |
Secondary | Total platelet count | Total platelet count (units per milliliters) | 16 weeks | |
Secondary | PDW | platelet distribution width (fL = femtoliters) | 16 weeks | |
Secondary | IPC | immature platelet count (platelets/microliter) | 16 weeks | |
Secondary | IPF | Immature platelet fraction (%) | 16 weeks | |
Secondary | H-IPF | Highly immature platelet fraction (%) | 16 weeks | |
Secondary | ROTEM | Thromboelastometry | 16 weeks | |
Secondary | TGF-beta | Transforming growth factor beta | 16 weeks | |
Secondary | sP-selectin | Soluble platelet selectin | 16 weeks | |
Secondary | Thrombomodulin | Thrombomodulin | 16 weeks |