Comparison Between Haparin and Herodin in HD

Haemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112262
• Other study ID #: heparin and herodin in HD
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 20, 2023
• Est. completion date: September 2026

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Basma Rabiey, Master
• Phone: 01128066349
• Email: basmarabiey639[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemodialysis

Intervention

Drug:
• Heparin
Comparison between heparin and hirudin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basma Rabiey

References & Publications (1)

Dangas GD, Lefevre T, Kupatt C, Tchetche D, Schafer U, Dumonteil N, Webb JG, Colombo A, Windecker S, Ten Berg JM, Hildick-Smith D, Mehran R, Boekstegers P, Linke A, Tron C, Van Belle E, Asgar AW, Fach A, Jeger R, Sardella G, Hink HU, Husser O, Grube E, Deliargyris EN, Lechthaler I, Bernstein D, Wijngaard P, Anthopoulos P, Hengstenberg C; BRAVO-3 Investigators. Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2860-2868. doi: 10.1016/j.jacc.2015.10.003. Epub 2015 Oct 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bleeding events and efficacy of dialysis during dialysis	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.	Baseline