Efficacy and safety of 6 % hydroxyethyl starch 130/0.4 (Voluven®) vs. 5% HSA in volume replacement therapy during elective open-heart surgery in paediatric patients

Fresenius Kabi Deutschland GmbH0 个研究点目标入组 60 人开始时间: 2008年12月15日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Male or female paediatric patient, 2 to 12 years of age, suffering from congenital heart-disease and undergoing elective open-heart surgery requiring ECC;
•2. Signed parental written informed consent and patient assent where achievable
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Known or suspected allergy to hydroxyethyl starch (such as rash), including its ingredients (inclusive corn) and related drugs;
•2. Known or suspected allergy to human albumin preparations, including its ingredients and related drugs;
•3. Known contraindication against scheduled concomitant medication;
•4. Total ECC volume < 400 mL;
•5. ASA > III;
•6. Patients with abnormal haemostasis (fibrinogen < 100mg/dl, or INR above 1.5, or platelet count < 100 x109/L, or aPTT: 1.5 times above upper limit of normal);
•7. Renal disease with oliguria or anuria not related to hypovolemia;
•8. Fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure;
•9. Patients receiving dialysis treatment;
•10. Intracranial bleeding;
•11. Severe hypernatremia or severe hyperchloremia;
•12. Risk of non-compliance with study protocol;
•13. Participation in a clinical drug trial within the last two months or concomitantly to this study;

发起方