NCT01304433

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 28, 2011

Status Verified

October 1, 2011

Enrollment Period

2.3 years

First QC Date

February 21, 2011

Last Update Submit

October 27, 2011

Conditions

Plasma Volume Replacement

Outcome Measures

Primary Outcomes (1)

  • number of adverse drug reactions

    up to 48 hours

Secondary Outcomes (1)

  • change in haemodynamics during surgery or intensive care unit stay

    up to 48 hours

Study Arms (1)

1

hydroxyethyl starch (HES) 130/0.42

Drug: Venofundin 6% / Tetraspan 6%

Interventions

Venofundin 6% / Tetraspan 6%DRUG

Venofundin 6% / Tetraspan 6%

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients

You may qualify if:

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

You may not qualify if:

  • contraindications as listed for HES 130/0.42

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu Province, 210029, China

Location

The Sixth Hospital of Shanghai

Shanghai, 200032, China

Location

The First Hospital of Shanghai

Shanghai, 200080, China

Location

Dong Fang Gan Dan Hospital of Shanghai

Shanghai, 200438, China

Location

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 50586, Malaysia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2011

First Posted

February 25, 2011

Study Start

January 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 28, 2011

Record last verified: 2011-10

Locations

MY(1)CN(5)