Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients

Surgery Clinical Trial

Official title:

Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806533
• Other study ID #: HC-O-H-0509
• Status: Completed
• Phase: N/A
• First received: December 10, 2008
• Last updated: May 15, 2009
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1130
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• Age =12 years

• Risk of anaesthesia: American Society of Anaesthesiologists (ASA) risk score: I - III

• infusion of Venofundin 6% or of Tetraspan 6%

• elective intervention

Exclusion Criteria:

• contraindications according to SmPC

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)
solution for intravenous infusion applied according to SmPC

Locations

Country	Name	City	State
Austria	Donauspital SMZ-OST	Vienna
Czech Republic	Clinic of Children's Anaesthesiology and Resuscitation	Brno
Czech Republic	Clinic of Anaesthesiology and Resuscitation	Praha
Germany	Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden	Dresden
Germany	Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover	Hannover
Germany	Klinikum Mannheim	Mannheim
Germany	Olgahospital	Stuttgart
Italy	S. Orsola Hospital, University hospital	Bologna
Netherlands	Academic Mesich Centrum (AMC)	Amsterdam
Netherlands	Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ)	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany,  Italy,  Netherlands, 

References & Publications (1)

Sümpelmann R, Kretz FJ, Gäbler R, Luntzer R, Baroncini S, Osterkorn D, Haeger MC, Osthaus WA. Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in children: preliminary results of a European Prospective Multicenter Observational Postauthorization Safety Study (PASS). Paediatr Anaesth. 2008 Oct;18(10):929-33. doi: 10.1111/j.1460-9592.2008.02696.x. Epub 2008 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adverse events		peri-operative	Yes