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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02232412

Enrollment

Registered

2014-09-05

Start date

2014-09-30

Completion date

2015-03-31

Last updated

2015-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
regional cerebral oxygen saturation (rSO2)	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.

Countries

Germany

Outcome results