Comparison Between Haparin and Herodin in HD

Sponsor

Basma Rabiey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06112262

Collaborator

(none)

Enrollment

32.4

Anticipated Duration (Months)

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Haemodialysis	Drug: Heparin	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 20, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patient age between 18:70
Haemodialysis duration less than 6 months
Agree to participate in the study

Exclusion Criteria:

AKI
patients with impaired coagulation profile
Decompensated liver disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Basma Rabiey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Basma Rabiey, Principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT06112262

Other Study ID Numbers:

heparin and herodin in HD

First Posted:

Nov 1, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heparin

Hirudins

Study Results

No Results Posted as of Nov 7, 2023