Comparison of the efficacy and safety of three different solutions for restoring blood volume after bleeding during surgery of pancreatic cancer.

• Conditions: Intraoperative plasma volume replacement requirement in elective surgery of the pancreatic head (pylorus preserving pancreatic-duodenectomy, PPPD); MedDRA version: 14.0Level: LLTClassification code 10059909Term: Volume plasmaSystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2008-004175-22-DE
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-27
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified