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
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|
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|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|
- 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.
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
|University Hospital Frankfurt|
|Frankfurt am Main, Hessen, Germany, 60590|
|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|