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Clinical Trials/EUCTR2008-004175-22-DE
EUCTR2008-004175-22-DEActive, not recruitingNot Applicable

PROSPECTIVE, CONTROLLED, DOUBLE-BLIND, RANDOMIZED MULTICENTRIC STUDY ON THE EFFICACY AND SAFETY OF A TARGET CONTROLLED PLASMA VOLUME REPLACEMENT THERAPY WITH A HYPER-ONCOTIC BALANCED HES 130/0.42 SOLUTION VS AN ISO-ONCOTIC BALANCED HES 130/0.42 SOLUTION COMPARED TO A BALANCED ELECTROLYTE SOLUTION IN ELECTIVE SURGERY OF THE PANCREATIC HEAD - HES 130/042 10% vs 6% PPPD

B. Braun Melsungen AG0 sitesStarted: January 27, 2009Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- Male or female patients older than18 years of age and less than 80 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine).
  • •- Patients scheduled to undergo elective surgery of the pancreatic head (e.g. PPPD)
  • •- Patients who are willing to give of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 200
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

  • •- Patients of ASA-class > III
  • •- Heart failure defined as NYHA class>2
  • •- Aneurysm of the ascending and thoracic aorta
  • •- Patients with Zenker’s diverticle
  • •- Local oesophageal disease (oesophageal stricture, oesophageal varices, previous oesophageal surgery in past 6 months before study inclusion, pharyngeal pouch)
  • •- Patients receiving haemodialysis
  • •- Patients with known bleeding diatheses
  • •- Any bleeding disorder known from patient’s history
  • •- Patients with a haematocrit ? 25% despite pre-op transfusion
  • •- Renal insufficiency (serum creatinine > 130 µmol/l or >1.5 mg/dl) or oliguria or anuria
  • •- Impaired hepatic function defined as MELD > 10 or liver cirrhosis Child-Pugh B or C
  • •- Additional contra-indications for either Tetraspan 6%, Tetraspan 10% and Sterofundin Iso
  • •- Pregnancy or lactation period
  • •- Simultaneous participation in another interventional clinical trial (AMG or MPG studies)
  • •- Emergencies

Investigators

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