NCT00854217

Brief Summary

Several studies have highlighted the cardioprotective effects of acute normovolemic hemodilution during cardiac surgery. The aim of our study is to show that an increase in endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute normovolemic hemodilution against ischemia-reperfusion phenomena.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 3, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

March 2, 2009

Last Update Submit

March 2, 2011

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Decrease in Troponin -I values

    4 h

Study Arms (1)

placebo, hemodilution

PLACEBO COMPARATOR
Procedure: acute normovolemic hemodilution

Interventions

acute normovolemic hemodilutionPROCEDURE
placebo, hemodilution

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients between 18 and 80 years old undergoing CABG with or without cardiopulmonary bypass

You may not qualify if:

  • emergencies
  • redo operations
  • combined surgery
  • men with Hb\< 120g/dL and women with Hb\< 110g/ dL
  • patients with preoperative creatinine\> 2.2 mg/dL
  • poor ventricular function (EF \< 50%)
  • subjects with a pulmonary disease, hepatic disease
  • subjects with carotid stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires saint Luc

Brussels, 1200, Belgium

Location

Related Publications (2)

  • Licker M, Sierra J, Kalangos A, Panos A, Diaper J, Ellenberger C. Cardioprotective effects of acute normovolemic hemodilution in patients with severe aortic stenosis undergoing valve replacement. Transfusion. 2007 Feb;47(2):341-50. doi: 10.1111/j.1537-2995.2007.01111.x.

    PMID: 17302782BACKGROUND

  • Licker M, Ellenberger C, Sierra J, Kalangos A, Diaper J, Morel D. Cardioprotective effects of acute normovolemic hemodilution in patients undergoing coronary artery bypass surgery. Chest. 2005 Aug;128(2):838-47. doi: 10.1378/chest.128.2.838.

    PMID: 16100176BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

December 1, 2010

Last Updated

March 3, 2011

Record last verified: 2011-03

Locations

BE(1)