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Comparison Between Haparin and Herodin in HD

Comparison of the Effecta and Drawbacks of Heparin Versus Hirudin Drugs in Haemodialysis Patients in Assiut University Hospitals

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06112262
Enrollment
98
Registered
2023-11-01
Start date
2023-12-20
Completion date
2026-09-30
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemodialysis

Brief summary

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?

Detailed description

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.

Interventions

DRUGHeparin

Comparison between heparin and hirudin

Sponsors

Basma Rabiey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of bleeding events and efficacy of dialysis during dialysisBaselinepatients will be investigated with aPTT before and after each of the following sessions (HD1, HD4, HD8), CBC/ week, number of clotting events, number of bleeding tendency, duration of fistula closure, to assess anticoagulant efficacy , and BUN, Serum creatinine, urea reduction ratio to assess dialysis efficacy.

Contacts

Primary ContactBasma Rabiey, Master
basmarabiey639@gmail.com01128066349

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026