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

Cardiac Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247051
• Other study ID #: PRE001AHK
• Status: Completed
• Phase: N/A
• First received: November 23, 2010
• Last updated: August 26, 2011
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 78 Years to 95 Years

Eligibility

Inclusion Criteria:

• Age > 78 years

• CPB

Exclusion Criteria:

• Hb <12 mg/dl

• Off pump surgery

Study Design

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardio Pulmonary Bypass
• Priming

Intervention

Procedure:
• Precoating
preoperative filling of heart lung machine with patients blood
• Standard priming
preoperative filling of heart lung machine with colloids

Locations

Country	Name	City	State
Germany	Goethe University	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss		24 hours	No
Secondary	Inflammatory response		one week	No