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Safety Profile of Hydroxyethyl Starch

NCT ID: NCT01304433

Last Updated: 2011-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Plasma Volume Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

hydroxyethyl starch (HES) 130/0.42

Venofundin 6% / Tetraspan 6%

Intervention Type DRUG

Venofundin 6% / Tetraspan 6%

Interventions

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Venofundin 6% / Tetraspan 6%

Venofundin 6% / Tetraspan 6%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with ASA risk score ≤ III,
* non-emergency patients, i.e. elective surgery

Exclusion:

* contraindications as listed for HES 130/0.42
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B. Braun Melsungen AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu Province, , China

Site Status

The Sixth Hospital of Shanghai

Shanghai, , China

Site Status

The First Hospital of Shanghai

Shanghai, , China

Site Status

Dong Fang Gan Dan Hospital of Shanghai

Shanghai, , China

Site Status

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, Malaysia

Site Status

Countries

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China Malaysia

Other Identifiers

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HC-O-H-0811

Identifier Type: -

Identifier Source: org_study_id