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

• 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: UCSF Benioff Children's Hospital Oakland
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	End-tidal Carbon Monoxide Subjects	End-tidal Carbon Monoxide Controls
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

Baseline Characteristics

Arm/Group Title		End-tidal Carbon Monoxide Subjects	End-tidal Carbon Monoxide Controls	Total
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
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

Outcome Measures

1. Primary Outcome

Title	End-Tidal Carbon Monoxide
Description	Compare ETCO between subjects and controls
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	End-tidal Carbon Monoxide Subjects	End-tidal Carbon Monoxide Controls
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	End-tidal Carbon Monoxide Subjects	End-tidal Carbon Monoxide Controls
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%)
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%)
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%)

Limitations and Caveats

A limitation of the data is the small number of subjects and that it was conducted under controlled circumstances in the clinic.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Ashutosh Lal, MD
• Organization: UCSF Benioff's Children's Hospital Oakland
• EMail: Ashutosh.Lal@ucsf.edu

Publications:

Lal A, Patterson L, Goldrich A, Marsh A. Point-of-care end-tidal carbon monoxide reflects severity of hemolysis in sickle cell anemia. Pediatr Blood Cancer. 2015 May;62(5):912-4. doi: 10.1002/pbc.25447. Epub 2015 Feb 14.

• 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