Plasma Volume ReplacementNCT01304433
Safety Profile of Hydroxyethyl Starch
An observational study of Plasma Volume Replacement, run by B. Braun Melsungen AG at 6 sites in 2 countries.
Trial summary
The study is primarily aimed to collect further data on the safety of the investigational product in a large patient population when used in routine clinical practice in the Asian-Pacific region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Volume Replacement
- What is being tested?
- Venofundin 6% / Tetraspan 6%
- How many people
- 1,000 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2009to May 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- patients with ASA risk score ≤ III,
- non-emergency patients, i.e. elective surgery
Who cannot join
- contraindications as listed for HES 130/0.42
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
China5 sites
Jiangsu Province Hospital
Nanjing, Jiangsu Province, 210029
The Sixth Hospital of Shanghai
Shanghai, 200032
The First Hospital of Shanghai
Shanghai, 200080
Dong Fang Gan Dan Hospital of Shanghai
Shanghai, 200438
Xuzhou Central Hospital
Xuzhou, Jiangsu
About this study
Official title: Evaluation on the Safety Profile of Hydroxyethyl Starch (HES) 130/0.42
The study is primarily aimed to collect further data on the safety of the investigational product in a large patient population when used in routine clinical practice in the Asian-Pacific region.
- Conditions
- Plasma Volume Replacement
- Being tested
- Venofundin 6% / Tetraspan 6%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venofundin 6% / Tetraspan 6%Drug
Venofundin 6% / Tetraspan 6%
| Study group | Role | What they receive |
|---|---|---|
| 1 | hydroxyethyl starch (HES) 130/0.42 Receives: Drug: Venofundin 6% / Tetraspan 6% |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of adverse drug reactions
Measured: up to 48 hours
Secondary outcomes (1)
change in haemodynamics during surgery or intensive care unit stay
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Volume ReplacementStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304433
- Sponsor's protocol ID
- HC-O-H-0811
- Status last verified
- Oct 2011
- First submitted
- 21 Feb 2011
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Safety Profile of Hydroxyethyl Starch (HES) 130/0.42
- ClinicalTrials.gov ID
- NCT01304433
- Acronym / sponsor ID
- HC-O-H-0811
- Conditions
- Plasma Volume Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 25 Feb 2011 (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.
The study is primarily aimed to collect further data on the safety of the investigational product in a large patient population when used in routine clinical practice in the Asian-Pacific region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Venofundin 6% / Tetraspan 6%hydroxyethyl starch (HES) 130/0.42 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (2 listed)
- patients with ASA risk score ≤ III,
- non-emergency patients, i.e. elective surgery
Key exclusion criteria (1 listed)
- contraindications as listed for HES 130/0.42
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 |
|---|---|---|
| Venofundin 6% / Tetraspan 6%Venofundin 6% / Tetraspan 6% | Drug | 1 |
Primary outcome
number of adverse drug reactions
Time frame: up to 48 hours
1 secondary outcome
change in haemodynamics during surgery or intensive care unit stay
Time frame: up to 48 hours
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 28 Oct 2011.
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Volume Replacement, run by B. Braun Melsungen AG at 6 sites in 2 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 2 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 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China, Malaysia. 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?
number of adverse drug reactions (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2011.