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

Sponsor

B. Braun Melsungen AG (Industry)

Overall Status

Completed

CT.gov ID

NCT00806533

Collaborator

(none)

1,130

Enrollment

Locations

Duration (Months)

113

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)

Study Design

Study Type:

Observational

Actual Enrollment :

1130 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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%) solution for intravenous infusion applied according to SmPC Other Names: Venofundin 6%, Tetraspan 6%

Arm

Intervention/Treatment

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%)

solution for intravenous infusion applied according to SmPC

Other Names:

Venofundin 6%, Tetraspan 6%

Outcome Measures

Primary Outcome Measures

incidence of adverse events [peri-operative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

B. Braun Melsungen AG

Investigators

Principal Investigator: R. Suempelmann, Prof. Dr., MHH Hannover

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00806533

Other Study ID Numbers:

HC-O-H-0509

First Posted:

Dec 11, 2008

Last Update Posted:

May 19, 2009

Last Verified:

May 1, 2009

Study Results

No Results Posted as of May 19, 2009