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Carbon Monoxide Measurement to Screen for Sickle Cell Disease (SCDCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02530242
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : October 19, 2020
Last Update Posted : June 9, 2021
Sponsor:
Collaborator:
Capnia, Inc.
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Sickle Cell Anemia
Interventions Device: End-tidal Carbon Monoxide Subjects
Device: End-tidal Carbon Monoxide Controls
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title End-tidal Carbon Monoxide Subjects End-tidal Carbon Monoxide Controls
Hide Arm/Group Description

Children between 1-18 years old with Sickle Cell Anemia

End-tidal Carbon Monoxide Subjects: ETCO monitor will be used to measure CO levels in subjects and controls.

Healthy children age and gender matched with subjects.

End-tidal Carbon Monoxide Controls: ETCO monitor will be used to measure CO levels in subjects and controls.

Period Title: Overall Study
Started 16 16
Completed 16 15
Not Completed 0 1
Reason Not Completed
excluded due to asthma and oxcarbazepine             0             1
Arm/Group Title End-tidal Carbon Monoxide Subjects End-tidal Carbon Monoxide Controls Total
Hide Arm/Group Description

Children between 1-18 years old with Sickle Cell Anemia

End-tidal Carbon Monoxide Subjects: ETCO monitor will be used to measure CO levels in subjects and controls.

Healthy children age and gender matched with subjects.

End-tidal Carbon Monoxide Controls: ETCO monitor will be used to measure CO levels in subjects and controls.

Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
9.4
(5 to 14)
9.7
(5 to 14)
9.5
(5 to 14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
11
  68.8%
11
  68.8%
22
  68.8%
Male
5
  31.3%
5
  31.3%
10
  31.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title End-Tidal Carbon Monoxide
Hide Description Compare ETCO between subjects and controls
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title End-tidal Carbon Monoxide Subjects End-tidal Carbon Monoxide Controls
Hide Arm/Group Description:

Children between 1-18 years old with Sickle Cell Anemia

End-tidal Carbon Monoxide Subjects: ETCO monitor will be used to measure CO levels in subjects and controls.

Healthy children age and gender matched with subjects.

End-tidal Carbon Monoxide Controls: ETCO monitor will be used to measure CO levels in subjects and controls.

Overall Number of Participants Analyzed 16 15
Median (Full Range)
Unit of Measure: ppm
4.35
(1.8 to 9.7)
.80
(.2 to 2.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title End-tidal Carbon Monoxide Subjects End-tidal Carbon Monoxide Controls
Hide Arm/Group Description

Children between 1-18 years old with Sickle Cell Anemia

End-tidal Carbon Monoxide Subjects: ETCO monitor will be used to measure CO levels in subjects and controls.

Healthy children age and gender matched with subjects.

End-tidal Carbon Monoxide Controls: ETCO monitor will be used to measure CO levels in subjects and controls.

All-Cause Mortality
End-tidal Carbon Monoxide Subjects End-tidal Carbon Monoxide Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
End-tidal Carbon Monoxide Subjects End-tidal Carbon Monoxide Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
End-tidal Carbon Monoxide Subjects End-tidal Carbon Monoxide Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
A limitation of the data is the small number of subjects and that it was conducted under controlled circumstances in the clinic.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ashutosh Lal, MD
Organization: UCSF Benioff's Children's Hospital Oakland
EMail: Ashutosh.Lal@ucsf.edu
Layout table for additonal information
Responsible Party: UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT02530242    
Other Study ID Numbers: 2015-013
First Submitted: August 19, 2015
First Posted: August 21, 2015
Results First Submitted: September 23, 2020
Results First Posted: October 19, 2020
Last Update Posted: June 9, 2021