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

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ClinicalTrials.gov Identifier: NCT02232412
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Dania Fischer, Johann Wolfgang Goethe University Hospital

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.


Condition or disease
Effect of RBC Transfusions on Cerebral Oxygen Saturation

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients requiring haemotherapy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232412


Locations
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Germany
University Hospital Frankfurt
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Study Director: Kai D Zacharowski, MD, PhD, FRCA University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
Study Chair: Patrick Meybohm, MD University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
Principal Investigator: Dania P Fischer, MD University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
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Responsible Party: Dr Dania Fischer, Dr. Dania Fischer, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT02232412    
Other Study ID Numbers: NIRS-2014
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Dr Dania Fischer, Johann Wolfgang Goethe University Hospital:
Anemia
NIRS
Near Infrared Spectroscopy
RBC transfusion
critical ill
regional cerebral oxygen saturation
tissue oxygenation
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes