Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santiago R. Leal-Noval, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT00566709
First received: November 29, 2007
Last updated: March 21, 2016
Last verified: March 2016
Results First Received: November 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Traumatic Brain Injury
Subarachnoid Hemorrhage
Intracerebral Hemorrhage
Intervention: Procedure: Red blood cells transfusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
RBCT Based on rSO2 Value

Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.

Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)

RBCT Based on Hemoglobin Level Value

Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.

Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)


Participant Flow:   Overall Study
    RBCT Based on rSO2 Value     RBCT Based on Hemoglobin Level Value  
STARTED     51     51  
COMPLETED     46     51  
NOT COMPLETED     5     0  
Protocol Violation                 5                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patient included into to "Intention to treat" analysis

Reporting Groups
  Description
RBCT Based on rSO2 Value

Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.

Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)

RBCT Based on Hemoglobin Level Value

Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.

Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)

Total Total of all reporting groups

Baseline Measures
    RBCT Based on rSO2 Value     RBCT Based on Hemoglobin Level Value     Total  
Number of Participants  
[units: participants]
  51     51     102  
Age  
[units: years]
Mean (Standard Deviation)
  45.2  (18.3)     46.1  (16.3)     45.6  (17.3)  
Gender  
[units: participants]
     
Female     16     20     36  
Male     35     31     66  
Hemoglobin (g/L)  
[units: g/L]
Mean (Standard Deviation)
  110.9  (21.2)     114  (21.6)     112.4  (21.3)  
Arterial Hypertension (n)  
[units: participants]
     
Yes     14     15     29  
No     37     36     73  
Diabetes mellitus (n)  
[units: participants]
     
Yes     2     5     7  
No     49     46     95  
APACHE II score [1]
[units: units on a scale]
Mean (Standard Deviation)
  14.6  (4.8)     13.8  (4.2)     14.1  (4.5)  
GCS [2]
[units: units on a scale]
Median (Inter-Quartile Range)
  9  
  (7 to 12)  
  9  
  (7 to 11)  
  9  
  (7 to 11)  
ISS score (N=30, 27) [3]
[units: units on a scale]
Mean (Standard Deviation)
  28.0  (9.8)     29.0  (9.6)     28.5  (9.6)  
Hunt and Hess scale (N=10, 13) [4]
[units: units on a scale]
Mean (Standard Deviation)
  4.1  (1.2)     4.1  (0.8)     4.1  (1)  
Fisher scale (N=10, 13) [5]
[units: units on a scale]
Mean (Standard Deviation)
  3.9  (0.3)     3.8  (0.4)     3.8  (0.4)  
Modified Grab score (N=11, 11) [6]
[units: units on a scale]
Mean (Standard Deviation)
  6.7  (3.9)     5.9  (3)     6.3  (3.4)  
PbrO2 (mm Hg) (N=17, 22) [7]
[units: mm Hg]
Mean (Standard Deviation)
  21.9  (5.7)     22.8  (5.6)     22.4  (5.6)  
CPP (mm Hg) (N=17, 22) [8]
[units: mm Hg]
Mean (Standard Deviation)
  73.9  (18.5)     72.9  (15.6)     73.4  (16.7)  
Diagnosis  
[units: participants]
     
Traumatic Brain Injury     30     27     57  
Subarachnoid hemorrhage     10     13     23  
Intra cerebral hemorrhage     11     11     22  
[1] Acute Physiology and Chronic Health Evaluation (APACHE) II score Minimun score:0, Maximum score: 71 Higher values represent worse result.
[2] Glasgow Coma Scale Minimun: 3; Maximum: 15 Higher values represent better outcome
[3]

Injury severity score (ISS) Minimum: 0; maximum: 75 Higher values represent worse outcome

ISS is only collected in patients with traumatic brain injury (N=57)

  • 30 into rSO2 arm
  • 27 into hemoglobin arm
[4]

Hunt and Hess scale for assessing the severity of patients with subarachnoid hemorrhage Minimum: 1; Maximum: 5 Higher values represent worse outcome

Only 23 patients with subarachnoid hemorrhage are included.

  • 10 into rSO2 arm
  • 13 into hemoglobin arm
[5]

Computer tomography Fisher Scale

Minimum: 1; Maximum: 4

Higher values represent worse outcome

Only 23 patients with subarachnoid hemorrhage are included

  • 10 into rSO2 arm
  • 13 into hemoglobin arm
[6]

Modified Graeb score for intra cerebral hemorrhage Minimum: 0; maximum: 42.

Higher values represent worse outcome

Only 22 patients with intra cerebral hemorrhage are included

  • 11 into rSO2 arm.
  • 11 into hemoglobin arm.
[7]

Pressure brain regional oxygen: PbrO2

Only 39 patients monitored with a PbrO2 probe are included:

  • 17 into rSO2 arm
  • 22 into hemoglobin arm
[8]

Cerebral perfusion pressure (CPP)

Only 39 patients monitored with a PbrO2 probe are included:

  • 17 into rSO2 arm
  • 22 into hemoglobin arm



  Outcome Measures
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1.  Primary:   Number of Units of Packed Red Blood Cell Transfused   [ Time Frame: duration of the protocol, an average of 15 days ]

2.  Primary:   Percentage of Transfused Patients in Each Group   [ Time Frame: duration of the protocol, an average of 15 days ]

3.  Secondary:   Hospital Mortality   [ Time Frame: length of the hospital stay, an average of 20 days ]

4.  Secondary:   Length of Intensive Care Unit (ICU) Stay   [ Time Frame: The length of ICU stay, an avarege of 17 days ]

5.  Secondary:   Long-term Mortality   [ Time Frame: 1-year after hospital discharge ]

6.  Secondary:   Unfavorable Glasgow Outcome Scale (GOS)   [ Time Frame: At hospital discharge, an average of 21 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limited adherence to the protocol in the rSO2 arm


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Santiago R Leal-Noval, MD, PhD
Organization: University Hospital "Virgen del Rocío"
phone: 0034954012528
e-mail: srlealnoval@gmail.com



Responsible Party: Santiago R. Leal-Noval, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT00566709     History of Changes
Other Study ID Numbers: PI-0157/2006
PI 157/06
Study First Received: November 29, 2007
Results First Received: November 20, 2015
Last Updated: March 21, 2016
Health Authority: Spain: Ethics Committee