Clinical trial NCT02232412: Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients
Official title: Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of RBC Transfusions on Cerebral Oxygen Saturation
Keywords: Anemia
NIRS
Near Infrared Spectroscopy
RBC transfusion
critical ill
regional cerebral oxygen saturation
tissue oxygenation
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2014-09-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients requiring haemotherapy

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.


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

Primary outcomes:
measure: regional cerebral oxygen saturation (rSO2)
timeFrame: 24-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
name: Kai D Zacharowski, MD, PhD, FRCA
role: STUDY_DIRECTOR
affiliation: University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
name: Patrick Meybohm, MD
role: STUDY_CHAIR
affiliation: University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
name: Dania P Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References: