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

• Conditions: Volume replacement therapy during elective open-heart surgery in paediatric patients; MedDRA version: 9.1Level: LLTClassification code 10048935Term: Open heart surgery

• Registration Number: EUCTR2008-006749-18-BE
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified