Efficacy and local tolerability of topically applied heparin (Heparin2,400 IU/ml Cutaneous Spray) on the suitability of newlyconstructed primary arteriovenous Fistulas in haemodialysedpatients

Conditions: This placebo-controlled, randomized and double-blinded pilot study aims to confirm the previousstudy performed by Stuard et al. (2010) by proving clinically efficacy and local tolerability of topicallyapplied heparin (Heparin 2,400 IU /ml Cutaneous Spray) in comparison to placebo on suitability ofnewly constructed primary arteriovenous fistulas in haemodialysed patients AVF at 7 weeks (±1week) after first study drug administration.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Registration Number: EUCTR2011-000455-16-AT

Lead Sponsor: CYATHUS EXQUIRERE PharmaforschungsGmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 56

Inclusion Criteria

• Male and/or female outpatients
• Aged over 18 years
• Stage 4 or 5 Chronic kidney Disease according to KDOQI classification
• Surgery to create an arteriovenous fistula in the lower arm is planned
• If female of childbearing potential: agree to maintain reliable birth control throughout
the study and negative (urine) pregnancy test
• Subject, who understand the meaning of the study and would be co-operative and
sufficiently reliable to use the medication as instructed.
• Subject has provided written informed consent prior to undergoing any study procedure.
• Patient is on stable daily dose of a thrombocyte aggregation inhibitor (acetyl salicylic
acid 50-100 mg, clopidogrel 75 mg or ticlopidin 250 -500mg)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known hypersensitivity to any component of the study medication
• Subject mentally not capable of adhering to the protocol
• History of previous arm (side of planned AVF), neck, or chest surgery/trauma
• Anticipated kidney transplant from living donor within the next 3 months
• Presence of any comorbidity that limits patient’s life expectancy to less than 6 months.
• Subject who is considered incompetent to give an informed consent
• Pregnancy / lactation or intention to fall pregnant during the time course of the study
• Women of childbearing potential who are not using adequate contraception
• Known bleeding disorder or established diagnosis of active or suspected bleeding
• Platelet count less than 80 x 109/L
• Uncontrolled hypertension: Diastolic blood pressure > 115 mm Hg or Systolic blood
pressure > 200 mm Hg
• Subject is unable to comply fully with trial requirements according to investigator’s
opinion
• Participation in any other clinical trial within the previous 30 days