Study of Cerebral Tissue Oxygenation During Transfusion in Traumatic Brain Injury

NCT01728831 | Completed

• 1 other identifier: 11-294
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal aims to provide some objective, non-invasively achieved, physiologically relevant data in order to provide some rational basis for decision-making for transfusion in sTBI. Specifically this proposal is an observational study of transfusion and brain tissue saturation in sTBI patients. The results will illustrate to what degree brain tissue oxygenation is critically dependent on the degree of anemia in sTBI and help in the decision of whether transfusion might be helpful.

Conditions

TBI (Traumatic Brain Injury); Acute Brain Injuries

Keywords

Red Cell Transfusion; Cerebral tissue oxygenation; Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Applicability of a 4 wavelength near-infrared spectroscopy (NIRS) to monitor the CHANGE in absolute cerebral oximetry over time

  After the physician in charge for the patient decides a PRBC transfusion is needed, the FORE-SIGHT probe will be placed on the patient's forehead. A single PRBC unit will be transfused over 30 - 60 minutes. Recording will be started 60 minutes before the transfusion and continued for up to 10 hours after the PRBC unit.

  Compare the change from the start of the transfusion until 10 hours later.

Secondary Outcomes (1)

• The impact of PRBC transfusion on absolute cerebral oximetry compared to peripheral values over time.

  Level of hemoglobin and hematocrit on admission, before transfusion and hourly after the transfusion for up to 5 hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 Patient with clinical diagnosis of severe TBI and GCS \<9 and Age \> 18 years old

You may qualify if:

• Age \> 18 years old
• Patient with clinical diagnosis of severe TBI and GCS \<9
• Patient requiring PRBC transfusion with a qualifying Hb\< 10/dL

You may not qualify if:

• Inability to place the NIRS probes on the patients (facial fractures, facial laceration, etc.).
• Deficient signal of SctO2 impeding its proper valuation
• Active coronary ischemia as judged by dynamic ischemic ECG changes and/ or positive troponin levels not due to myocardial contusion.
• Active hemorrhage: Example
• Bleeding into the chest, abdomen or retro-peritoneum likely to require surgery +/- embolization
• Pelvic fracture likely to require surgery +/- embolization
• More than two long bone fractures requiring operative fixation
• Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
• Systolic BP \<90mmHg
• Heart rate \> 120bpm
• GCS=3 + un-reactive pupils

Sponsors & Collaborators

• Unity Health Toronto: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andrew Baker, MD

  Medical Director, Critical Care

  STUDY DIRECTOR

• Victoria A McCredie, MBChB

  Sunnybrook Health Sciences Center, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2012
• First Posted: November 20, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-11

Locations

CA (1)