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

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

Sponsors

Lead sponsor: Johann Wolfgang Goethe University Hospital

Source 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.

Overall Status Completed
Start Date September 2014
Completion Date March 2015
Primary Completion Date March 2015
Study Type Observational
Primary Outcome
Measure Time Frame
regional cerebral oxygen saturation (rSO2) 24-48 hours
Enrollment 25
Condition
Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Location
facility
University Hospital Frankfurt
Location Countries

Germany

Verification Date

March 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Johann Wolfgang Goethe University Hospital

Investigator full name: Dr Dania Fischer

Investigator title: Dr. Dania Fischer

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov