NCT00308126

Brief Summary

Purpose: To compare the incidence of post-surgery complications and evaluate relevant parameters within 28 days after an operation in HES (130/0.4) and albumin treated groups Study Design: Open-label, active controlled, parallel group, randomized, multi-center study. Per protocol, 624 patients required in 6 study centers. Hypothesis: No difference in rate of postoperative (post-op) complications between HES and albumin groups

Trial Health

87
On Track

Trial Health Score

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

Enrollment
624

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

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

June 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

December 11, 2007

Status Verified

March 1, 2006

First QC Date

March 28, 2006

Last Update Submit

December 7, 2007

Conditions

Postoperative Complications

Keywords

Abdominal operation

Outcome Measures

Primary Outcomes (1)

  • Occurrence of any postoperative complication stipulated in protocol within 28 days after abdominal operation

Secondary Outcomes (1)

  • 28th day after abdominal operation

Interventions

Hydroxyethyl Starch 130/0.4 (Voluven)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 75, male or female
  • After abdominal operation of medium scale or above (including but not limited to: gastric cancer eradication, rectal cancer eradication, hepatic lobectomy, corpus and cauda pancreatectomy)
  • Hemoglobin (Hb) no less than 70g/L; serum albumin no less than 30 g/L before operation
  • Blood loss during operation no more than 2000 ml

You may not qualify if:

  • Known to be allergic to HES or albumin
  • Urine output less than 500 ml/24 hours
  • Intra-cranial hemorrhage
  • Liver transplantation
  • Use colloid other than study drugs
  • Lung edema
  • Pregnant, lactating female
  • Participate in other clinical study within 30 days
  • Poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College (PUMC) Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Hydroxyethyl Starch DerivativesHES 130-0.4

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Yupei Zhao

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

June 1, 2005

Study Completion

September 1, 2006

Last Updated

December 11, 2007

Record last verified: 2006-03

Locations

CN(1)