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

CYATHUS EXQUIRERE PharmaforschungsGmbH0 个研究点目标入组 56 人开始时间: 2011年3月30日最近更新: 2014年5月12日

适应症

试验速览

暂无简介。

•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

•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
•Participation in any other clinical trial within the previous 30 days

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