NCT01127477View on ClinicalTrials.gov

Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Interventions
DRUG

1: Hydroxyethyl starch 130/0.4, 6 %

1: Up to 50 ml 6 % hydroxyethyl starch 130/0.4/kg body weight administered intravenously from start of surgery (skin incision) until two hours after end of surgery.

Trial Locations (4)

060-8543

Sapporo Medical University, School of Medicine, Sapporo

700-8558

Okayama University, Okayama

157-8535

National Center for Child Health and Development, Tokyo

162-8666

Tokyo Women's Medical University, Tokyo

Sponsors
All Listed Sponsors
lead

Fresenius Kabi Japan

INDUSTRY

NCT01127477 - Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery | Biotech Hunter | Biotech Hunter