SurgeryNCT00806533
Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
An observational study of Surgery, run by B. Braun Melsungen AG at 10 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Surgery
- What is being tested?
- HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)
- Type of treatment
- Injection or infusion
- How many people
- 1,130 participants
- Where
- 10 sitesin 5 countries
- Study dates
- May 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: paediatric patients aged up to 12 years
Who may be able to join
- 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
Who cannot join
- contraindications according to SmPC
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Germany4 sites
Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden
Dresden
Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover
Hanover
Klinikum Mannheim
Mannheim
Olgahospital
Stuttgart
Czechia2 sites
Clinic of Children's Anaesthesiology and Resuscitation
Brno
Clinic of Anaesthesiology and Resuscitation
Prague
Netherlands2 sites
Academic Mesich Centrum (AMC)
Amsterdam
Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ)
Rotterdam
About this study
Official title: Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years
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.
- Conditions
- Surgery
- Being tested
- HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)Drug
Also called Venofundin 6%, Tetraspan 6%
solution for intravenous infusion applied according to SmPC
| Study group | Role | What they receive |
|---|---|---|
| HES 130 / 0.42 | paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42 Receives: Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse events
Measured: peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,130 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- R. Suempelmann, Prof. Dr., Principal investigator, MHH Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806533
- Sponsor's protocol ID
- HC-O-H-0509
- Status last verified
- May 2009
- First submitted
- 10 Dec 2008
- Last updated
- 19 May 2009
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years
- ClinicalTrials.gov ID
- NCT00806533
- Acronym / sponsor ID
- HC-O-H-0509
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,130 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HES 130 / 0.42 | – | Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42 |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- paediatric patients aged up to 12 years
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- contraindications according to SmPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)Also: Venofundin 6%, Tetraspan 6%solution for intravenous infusion applied according to SmPC | Drug | HES 130 / 0.42 |
Primary outcome
incidence of adverse events
Time frame: peri-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2009.
- Background: PubMed 18647272Sumpelmann 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.
Related trials for Surgery
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Suempelmann, Prof. Dr. principal investigator
MHH Hannover
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by B. Braun Melsungen AG at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Czechia, Netherlands, Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adverse events (time frame: peri-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00806533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2009.