CClinicalTrials.gg
Sign In
CompletedNCT00806533Updated May 19, 2009

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

An observational study in Surgery, sponsored by B. Braun Melsungen AG. Completed at 10 sites in 5 countries. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2009-05-19.

Sponsored by B. Braun Melsungen AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,130
Ages
Up to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery
03

In context

Lead sponsor

B. Braun Melsungen AG is the lead sponsor of 46 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

paediatric patients aged up to 12 years

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

Exclusion Criteria:

  • contraindications according to SmPC
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,130 participants (actual)

Groups and cohorts

  • HES 130 / 0.42

    paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42

    Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)

Interventions

  • DrugHES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)

    solution for intravenous infusion applied according to SmPC

    Also known as: Venofundin 6%, Tetraspan 6%

06

What researchers measure

Primary outcomes

  1. incidence of adverse events

    Time frame: peri-operative

07

Study locations

10 sites
  • Donauspital SMZ-OST
    Vienna, Austria
  • Clinic of Children's Anaesthesiology and Resuscitation
    Brno, Czech Republic
  • Clinic of Anaesthesiology and Resuscitation
    Praha, Czech Republic
  • 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, 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
08

References and documents

Publications

  • 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. PubMed 18647272 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00806533
Lead sponsor
B. Braun Melsungen AG
First posted
Dec 11, 2008
Start date
May 2006
Primary completion
Dec 2008
Completion
Dec 2008
Last update
May 19, 2009

Study contacts

R. Suempelmann, Prof. Dr.
principal investigator · MHH Hannover

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

B. Braun Melsungen AG

Start the discussion