- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02232412
Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hessen
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Frankfurt am Main, Hessen, Germany, 60590
- University Hospital Frankfurt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24-48 hours
|
Collaborators and Investigators
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIRS-2014
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