Effect of RBC Transfusions on Cerebral Oxygen Saturation Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Frankfurt | Frankfurt am Main | Hessen |
| Lead Sponsor | Collaborator |
|---|---|
| Johann Wolfgang Goethe University Hospitals |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | regional cerebral oxygen saturation (rSO2) | 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 | No |