Trial Outcomes & Findings for Aspirin Prophylaxis in Sickle Cell Disease (NCT NCT00178464)

NCT ID: NCT00178464

Last Updated: 2017-11-06

Results Overview

Occurrence of individual serious adverse events and relationship to aspirin

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 11 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-11-06

Participant Flow

Participant milestones

Measure	Aspirin Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Aspirin Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Aspirin Prophylaxis in Sickle Cell Disease

Baseline characteristics by cohort

Measure	Aspirin n=11 Participants Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
Age, Categorical <=18 years	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Intention to treat

Occurrence of individual serious adverse events and relationship to aspirin

Outcome measures

Measure	Aspirin n=8 Participants Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
Number of Serious Adverse Events Unlikely	9 events
Number of Serious Adverse Events No relationship	6 events
Number of Serious Adverse Events Possible	0 events
Number of Serious Adverse Events Probable	0 events
Number of Serious Adverse Events Definite	0 events

PRIMARY outcome

Timeframe: 12 months

Population: Intention to treat

Occurrence of individual adverse events and relationship to aspirin

Outcome measures

Measure	Aspirin n=8 Participants Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
Number of Adverse Events No relationship	8 events
Number of Adverse Events Unlikely	3 events
Number of Adverse Events Possible	5 events
Number of Adverse Events Probable	1 events
Number of Adverse Events Definite	2 events

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

Adverse Events

Aspirin

Serious events: 8 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aspirin n=11 participants at risk Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
General disorders Fever resulting in Hospitalization	54.5% 6/11 • Number of events 7
Blood and lymphatic system disorders Severe Anemia resulting in hospitalization	9.1% 1/11 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia resulting in hospitalization	9.1% 1/11 • Number of events 1
Musculoskeletal and connective tissue disorders Vasoocclusive Crisis Pain resulting in hospitalization	18.2% 2/11 • Number of events 6
Blood and lymphatic system disorders Splenic Sequestration	9.1% 1/11 • Number of events 1
Respiratory, thoracic and mediastinal disorders Asthma resulting in hospitalization	9.1% 1/11 • Number of events 1
Musculoskeletal and connective tissue disorders Fracture resulting in hospitalization	9.1% 1/11 • Number of events 1
Respiratory, thoracic and mediastinal disorders Acute Chest Syndrome resulting in hospitalization.	9.1% 1/11 • Number of events 1
Nervous system disorders Abnormal MRA resulting in withdrawal from study.	9.1% 1/11 • Number of events 1

Other adverse events

Measure	Aspirin n=11 participants at risk Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
General disorders Fever	18.2% 2/11 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pneumonia	9.1% 1/11 • Number of events 1
Skin and subcutaneous tissue disorders Scabies	9.1% 1/11 • Number of events 1
Blood and lymphatic system disorders Bleeding per rectum	9.1% 1/11 • Number of events 3
Blood and lymphatic system disorders Epistaxis	18.2% 2/11 • Number of events 3
General disorders Pain	27.3% 3/11 • Number of events 3
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	9.1% 1/11 • Number of events 1
Gastrointestinal disorders Epigastric pain	9.1% 1/11 • Number of events 1
Ear and labyrinth disorders Otitis Media	9.1% 1/11 • Number of events 1
General disorders Allergic reaction	9.1% 1/11 • Number of events 1
Gastrointestinal disorders Tarry stool	9.1% 1/11 • Number of events 1

Additional Information

Dr. Norma B. Lerner

St. Christopher's Hospital for Children

Phone: 215 427-5261

Email: norma.lerner@drexelmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place