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

J

Johann Wolfgang Goethe University Hospital

Status

Completed

Conditions

Cardio Pulmonary Bypass
Cardiac Surgery
Priming

Treatments

Procedure: Precoating
Procedure: Standard priming

Study type

Interventional

Funder types

Other

Identifiers

NCT01247051
PRE001AHK

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

78 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 78 years
  • CPB

Exclusion criteria

  • Hb <12 mg/dl
  • Off pump surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Precoating
Experimental group
Treatment:
Procedure: Precoating
Standard priming
Active Comparator group
Treatment:
Procedure: Standard priming

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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