Comparison Between Haparin and Herodin in HD

Early Phase 1

Not yet recruiting

• Conditions: Haemodialysis
• Interventions: Drug: Heparin

• Registration Number: NCT06112262
• Lead Sponsor: Basma Rabiey

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.

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-31
• Status Verified: 2023-11
• Study First Posted: 2023-11-01
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-21
• Study Start: 2023-12-20
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heparin and Hirudin	Heparin	Anticoagulant in Hemodialysis

Primary Outcome Measures

Name	Time	Method
Number of bleeding events and efficacy of dialysis during dialysis	Baseline	patients 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.