NCT00364494

Brief Summary

An hematocrit of 21-25% is supposed to perform the best organ protection during cardiopulmonary bypass for cardiac surgery. The investigators want to establish the best timing for a transfusion (in patients with a predicted low hematocrit during cardiopulmonary bypass) and the efficacy of preprocedural hemodilution (in patients with a predicted high hematocrit during cardiopulmonary bypass) in patients undergoing cardiac surgery.

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Nov 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 14, 2009

Status Verified

August 1, 2009

Enrollment Period

5 months

First QC Date

August 11, 2006

Last Update Submit

August 13, 2009

Conditions

Kidney FailureIntraoperative Complications

Keywords

HematocritHemodilutionBlood TransfusionCardiopulmonary BypassMultiple Organ FailureSurgery, CardiacKidney FailureCardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • renal function

Secondary Outcomes (4)

  • other organ damage

  • prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay

  • sepsis

  • exitus

Interventions

Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)PROCEDURE

Subgroup 1,with Ht\<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht\>25% bleed or not

Eligibility Criteria

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

You may qualify if:

  • Undergoing cardiac surgery

You may not qualify if:

  • Age \< 18 years old
  • Not signing written consent
  • Age \< 65 years old (subgroup 1)
  • Emergency, aortic stenosis, main left coronary stenosis (subgroup 2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Renal InsufficiencyIntraoperative ComplicationsMultiple Organ Failure

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Giovanni Landoni, MD

    Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

    STUDY DIRECTOR

  • Giuseppe Crescenzi, MD

    Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 15, 2006

Study Start

November 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 14, 2009

Record last verified: 2009-08

Locations

IT(1)