Safety Profile of Hydroxyethyl Starch | NCT01304433

Studies
Safety Profile of Hydroxyethyl Starch

NCT01304433

Sponsor

B. Braun Melsungen AG

Status

Completed

Last Update Posted

Oct 28, 2011Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Plasma Volume Replacement

Interventions

Venofundin 6% / Tetraspan 6%

Countries

China
Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Feb 21, 2011

First Submission Date that Met QC Criteria

Feb 24, 2011

First Posted Date

Feb 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2011

Last Update Posted Date

Oct 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		hydroxyethyl starch (HES) 130/0.42	Drug: Venofundin 6% / Tetraspan 6%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venofundin 6% / Tetraspan 6%	Drug	Venofundin 6% / Tetraspan 6%	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of adverse drug reactions		up to 48 hours

Secondary Outcomes

Measure	Description	Time Frame
change in haemodynamics during surgery or intensive care unit stay		up to 48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

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

Exclusion:

contraindications as listed for HES 130/0.42

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuzhou Central Hospital		Xuzhou	Jiangsu		China
Jiangsu Province Hospital