Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01247051
First received: November 23, 2010
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

The study is a single-center, randomized, un-blinded treatment study in which patients (>78 years) with the use off a heart-lung machine were provided into two study arms.

Patient wit "precoating" have a filling of the machine with their own blood. In the comparator arm, a standard priming is used.


Condition Intervention
Priming
Cardiac Surgery
Cardio Pulmonary Bypass
Procedure: Precoating
Procedure: Standard priming

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • blood loss [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory response [ Time Frame: one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Precoating Procedure: Precoating
preoperative filling of heart lung machine with patients blood
Active Comparator: Standard priming Procedure: Standard priming
preoperative filling of heart lung machine with colloids

  Eligibility

Ages Eligible for Study:   78 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 78 years
  • CPB

Exclusion Criteria:

  • Hb <12 mg/dl
  • Off pump surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247051

Locations
Germany
Goethe University
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Arndt-H. Kiessling, Head cardiovascular research, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01247051     History of Changes
Other Study ID Numbers: PRE001AHK
Study First Received: November 23, 2010
Last Updated: August 26, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
priming
cardiac surgery
cardio pulmonary bypass
precoating

ClinicalTrials.gov processed this record on April 16, 2014