Safety Profile of Hydroxyethyl Starch

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01304433
First received: February 21, 2011
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Plasma Volume Replacement
Drug: Venofundin 6% / Tetraspan 6%

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation on the Safety Profile of Hydroxyethyl Starch (HES) 130/0.42

Resource links provided by NLM:


Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • number of adverse drug reactions [ Time Frame: up to 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change in haemodynamics during surgery or intensive care unit stay [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
hydroxyethyl starch (HES) 130/0.42
Drug: Venofundin 6% / Tetraspan 6%
Venofundin 6% / Tetraspan 6%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adult patients

Criteria

Inclusion:

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

Exclusion:

  • contraindications as listed for HES 130/0.42
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304433

Locations
China, Jiangsu
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
China
Jiangsu Province Hospital
Nanjing, Jiangsu Province, China, 210029
The Sixth Hospital of Shanghai
Shanghai, China, 200032
Dong Fang Gan Dan Hospital of Shanghai
Shanghai, China, 200438
The First Hospital of Shanghai
Shanghai, China, 200080
Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Sponsors and Collaborators
B. Braun Melsungen AG
  More Information

No publications provided

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01304433     History of Changes
Other Study ID Numbers: HC-O-H-0811
Study First Received: February 21, 2011
Last Updated: October 27, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014