Comparison of the Effecta and Drawbacks of Heparin Versus Hirudin Drugs in Haemodialysis Patients in Assiut University Hospitals
| Registry | NCT06112262 |
|---|---|
| Status | Unknown |
| Phase | Early Phase 1 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 98 (Estimated) |
| Sponsor | Basma Rabiey (Other) |
| Conditions | Haemodialysis |
| Interventions | Heparin (Drug) |
| Dates | start 2023-12-20 (estimated), primary completion 2025-09-01 (estimated), completion 2026-09-01 (estimated), first posted 2023-11-01, last updated 2023-11-21 |
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All trials for Haemodialysis All trials of Heparin
The goal of this study is to compare the efficacy and drawbacks of Heparin and Hirudin in Haemodialysis patients. The main question it aims to answer is:
which drug is more safe in Haemodialysis?
Extracorporeal thrombogenesis is a major problem associated with haemodialysis. The composition of the artificial membrane in the extracorporial system and large surface area to which the blood is exposed, contribute significantly to activation of the coagulation cascade and platelets. The use of anticoagulant is to prevent thrombotic occlusion of the dializer to ensure effective dialysis.
The most common anticoagulant options for Hemodialysis include unfractionated heparin (UFH), low-molecular weight heparin (LMWH), thrombin antagonists, and platelet inhibiting agents. The choice of anticoagulant for Haemodialysis should be determined by patient characteristics, local expertise, and ease of monitoring.
Heparins are currently the anticoagulants of choice in long-term haemodialysis (HD), but because of their shortcomings, including the increasing incidence of heparin-induced thrombocytopenia (HIT II), alternative anticoagulation is necessary, as there are several complication associated with its long term use, They include thrombocytopenia, increase bleeding tendency, osteoporosis, increase lipolytic activity and change of lipid pattern, activation of of lipolysis also leads to immunosuppressive effect.
Hirudin the most potent natural inhibitor of thrombin, it is a direct thrombin inhibitor and does not require endogenous cofactors. Hirudin inhibits all actions of thrombin and so effectively inhibit coagulation and prevent heparin resistant arterial type thrombosis when given in large enough doses. Hirudin has no adverse effect when it is used into human, because it is pharmacologically inert. Hirudin is also a weak immunogen.
Few researches evaluate the efficacy and drawbacks of Hirudin in HD patients.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Heparin and Hirudin | Experimental | Drug: Heparin | Anticoagulant in Hemodialysis |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: 1. patient age between 18:70 2. Haemodialysis duration less than 6 months 3. Agree to participate in the study Exclusion Criteria: 1. AKI 2. patients with impaired coagulation profile 3. Decompensated liver disease