Trial Outcomes & Findings for A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection (NCT NCT00576147)

Last Updated: 2018-11-07

Results Overview

We will report Sensitivity and Specificity of NIRS device as compared to CT scanner to detect hematomas of more than 3.5 mL in volume and less than 2.5 cm from the surface of the brain. Sensitivity is the ratio between true positives to all positive measurements. Specificity is the ratio between true negatives to all negative measurements.

Recruitment status

COMPLETED

Study phase

Target enrollment

431 participants

Primary outcome timeframe

2 years

Results posted on

2018-11-07

Participant Flow

Near-Infrared examinations performed on all patients within 30 minutes before the CT scan of the head and within 12 hours of their head injury

Participant milestones

Participant milestones
Measure	CT Scan The standard head CT done to head trauma patients
Overall Study STARTED	431
Overall Study COMPLETED	431
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CT Scan n=431 Participants The standard head CT done to head trauma patients
Age, Categorical <=18 years	46 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	333 Participants n=5 Participants
Age, Categorical >=65 years	52 Participants n=5 Participants
Age, Continuous	36.7 years STANDARD_DEVIATION 26 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants
Sex: Female, Male Male	323 Participants n=5 Participants
Region of Enrollment United States	306 participants n=5 Participants
Region of Enrollment India	125 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 431 Total patients enrolled; 365 total patients evaluated after 66 excluded for protocol violations; 269 Number of patients with no Intracranial Hemorrhage; 96 Number of patients with confirmed intrcranial hemorrhage; 50 Number of patients with Intracranial hemorrhage within detection limits of the device.

Outcome measures

Outcome measures
Measure	CT Scan n=365 Participants The standard head CT done to head trauma patients
1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. False Negatives	6 Number of participants
1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. True Positive	44 Number of participants Interval 74.9 to 95.0
1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. False Positive	25 Number of participants
1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. True Negatives	244 Number of participants

Adverse Events

CT Scan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Claudia Robertson

Baylor College of Medicine

Phone: (713) 798-8932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place