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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014