NCT06112262

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?

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P75+ for early_phase_1

Timeline
4mo left

Started Dec 2023

Typical duration for early_phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Dec 2023Sep 2026

First Submitted

Initial submission to the registry

October 27, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

October 27, 2023

Last Update Submit

November 19, 2023

Conditions

Haemodialysis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Heparin and Hirudin

EXPERIMENTAL

Anticoagulant in Hemodialysis

Drug: Heparin

Interventions

HeparinDRUG

Comparison between heparin and hirudin

Also known as: Hirudin
Heparin and Hirudin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • AKI
  • patients with impaired coagulation profile
  • Decompensated liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 26477635BACKGROUND

MeSH Terms

Interventions

HeparinHirudins

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesAntithrombin ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsProteins

Central Study Contacts

Basma Rabiey, Master

CONTACT

01128066349basmarabiey639@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 1, 2023

Study Start

December 20, 2023

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

November 21, 2023

Record last verified: 2023-11