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Clinical Trials/NCT02232412
NCT02232412
Completed
Not Applicable

Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients

Johann Wolfgang Goethe University Hospital1 site in 1 country25 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Effect of RBC Transfusions on Cerebral Oxygen Saturation
Sponsor
Johann Wolfgang Goethe University Hospital
Enrollment
25
Locations
1
Primary Endpoint
regional cerebral oxygen saturation (rSO2)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Critically ill patients are frequently transfused with red blood cell (RBC) units with the predominant intention to increase arterial oxygen content and thus oxygen delivery to the tissues.

To date, RBC transfusions have been proven effective in patients with profound anaemia or circulatory shock. However, the impact of the storage process and the so-called storage lesion on oxygen-carrying properties and, hence, the efficacy of RBC transfusion regarding tissue oxygenation are much debated at present. Alterations of RBC physiology have been comprehensively described ex vivo. Reduced deformability, increased adhesiveness and aggregability of stored RBC impair their rheological properties; anaerobic cellular metabolism with reduced contents of 2,3 bisphosphoglycerate and adenosine triphosphate (ATP) increases oxygen affinity and impairs oxygen release to the tissues.

This study aims to monitor the effect RBC transfusion has on the regional cerebral oxygen saturation (rSO2) of critically ill patients. rSO2 will be measured indirectly, using near infrared spectroscopy (NIRS) . Patients will be monitored once it looms that they might require RBC transfusion. The monitoring is continued for the time of transfusion and the hours afterwards.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
March 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johann Wolfgang Goethe University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Dania Fischer

Dr. Dania Fischer

Johann Wolfgang Goethe University Hospital

Eligibility Criteria

Inclusion Criteria

  • expected requirement of RBC transfusion
  • 18 yrs and older

Exclusion Criteria

  • severe traumatic brain injury (Glasgow coma scale \< 9), subarachnoid hemorrhage (Hunt and Hess scale ≥ 3) or intracranial hemorrhage
  • cerebral ischaemia
  • active bleeding
  • patients necessitating ongoing resuscitation
  • deficient signal of rSO2 impeding its proper valuation

Outcomes

Primary Outcomes

regional cerebral oxygen saturation (rSO2)

Time Frame: 24-48 hours

Regional cerebral oxygen saturation (rSO2) will be measured before, during and after RBC transfusion. As the decision to transfuse is multifactorial and the condition of critically ill patients often instable, time frames before, during and after transfusion may vary.

Study Sites (1)

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