Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years
1 other identifier
observational
1,130
5 countries
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2006
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 10, 2008
CompletedFirst Posted
Study publicly available on registry
December 11, 2008
CompletedMay 19, 2009
May 1, 2009
2.6 years
December 10, 2008
May 15, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of adverse events
peri-operative
Study Arms (1)
HES 130 / 0.42
paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42
Interventions
solution for intravenous infusion applied according to SmPC
Eligibility Criteria
paediatric patients aged up to 12 years
You may qualify if:
- 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
You may not qualify if:
- contraindications according to SmPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Donauspital SMZ-OST
Vienna, Austria
Clinic of Children's Anaesthesiology and Resuscitation
Brno, Czechia
Clinic of Anaesthesiology and Resuscitation
Prague, Czechia
Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden
Dresden, Germany
Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover
Hanover, Germany
Klinikum Mannheim
Mannheim, Germany
Olgahospital
Stuttgart, Germany
S. Orsola Hospital, University hospital
Bologna, Italy
Academic Mesich Centrum (AMC)
Amsterdam, Netherlands
Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ)
Rotterdam, Netherlands
Related Publications (1)
Sumpelmann R, Kretz FJ, Gabler 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.
PMID: 18647272BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
R. Suempelmann, Prof. Dr.
MHH Hannover
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 10, 2008
First Posted
December 11, 2008
Study Start
May 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
May 19, 2009
Record last verified: 2009-05