Details - CureSickleCell

Study ID	1024
Name	Comprehensive Sickle Cell Centers' (CSCC) -Dexamethasone
Contact Email	charles.quinn@utsouthwestern.edu
Acronym	CSCC-Dexamethasone
Period	2006 - 2008
Design	Clinical Trial
Study PI	Charles Quinn
Institution	Children's Hospital Medical Center, Cincinnati
URL	https://clinicaltrials.gov/ct2/show/NCT00530270
CTGovID	https://clinicaltrials.gov/ct2/show/NCT00530270
Funding Agency	NHLBI
Grant Number	5U54HL070587-07

Overview	This study tests the effectiveness of oral dexamethasone for the acute chest syndrome (ACS) of sickle cell disease (SCD) in children and adults in the context of standard supportive care. This study primarily aims to determine whether dexamethasone shortens the duration of signs and symptoms of and medical intervention for ACS.
Focus Areas	1. To determine whether dexamethasone decreases the duration of signs and symptoms of ACS. 2. To determine (1) whether dexamethasone reduces morbidity associated with ACS; (2) whether a tapered regimen of dexamethasone prevents rebound VOC; (3) whether dexamethasone modulates the endothelial phenotype to a less proadhesive, and procoagulant state, and to determine if the discontinuation of dexamethasone will be associated with a rebound in the expression of endothelial activation markers of adhesion and coagulation; (4) whether dexamethasone prevents subacute adverse effects of ACS on pulmonary function; and (5) whether dexamethasone modulates white cell activation and if the discontinuation of dexamethasone will be associated with a rebound in white cell activation.
Outcomes	1. The duration of signs and symptoms of ACS or duration of hospitalization, whichever is less. The duration of signs and symptoms of ACS is defined as the interval between study entry and the time at which tachypnea, hypoxemia, increased work of breathing, and thoracic pain have resolved and supplemental oxygen and ventilatory support are no longer utilized. 2. Clinical endpoints include: rating of pain, duration of hospitalization, supplemental oxygen, hypoxemia, and fever, number of transfusions, quantification of opioid use, rebound hospitalizations, pulmonary radiographic findings, and pulmonary function testing results. Laboratory endpoints include: VCAM1, ICAM1, P-selectin, L-selectin, vWF multimers, endothelial and monocyte microparticles, WBTF, NO, and sPLA2.

Data Location	RTI International
Biospecimen Available	Blood; Plasma; Serum; Urine; Cell;
Data Consent	Data from the trial are confidential and may not be disclosed without the written permission of the NHLBI; consent includes statement regarding data deidentification.
Biospecimen Consent	NA
Contact Consent	NA
Genomic Data	No

Age Range	5-99
No. Participants	12
Inclusion Criteria	New episode of ACS; diagnosis of ACS within preceding 24 hours; and provision of informed consent.
Exclusion Criteria	Prior participation in this study; corticosteroids contraindicated for comorbid conditions; corticosteroid treatment in preceding 2 weeks.

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Clinical status (146)

Behavior (0)

Blood (2)

Data Element	Variables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease	GENOTYP INCL2

Cancer (0)

Cardiovascular (5)

Data Element	Variables
Aneurysm
Cardiac Failure
Cardiovascular Problem	FLUID HYPER OTHSP REASON TREAT
Heart Problem

Digestive (0)

Endocrine (0)

Family MedHx (0)

General Health (0)

Genitourinary (0)

Immune (22)

Data Element	Variables
Fever	FEVER FEVER FEVER FEVERDA FEVERDA FEVERDT FEVERDT FEVERHR FEVERHR FEVERHR FEVERMI FEVERMI FEVERMI FEVERMO FEVERMO FEVERTM FEVERTM FEVERTM FEVERYR FEVERYR NOFEVER
HIV Infection
Immune Problem
Infection	EXCL11
Vaccination

Lymphatic (0)

Medical Event (33)

Data Element	Variables
Adverse event	ACT7SP ACTION1 ACTION2 ACTION3 ACTION4 ACTION5 ACTION6 ACTION7 ADVEXP AEYN DEVIAE HYPER HYPER ONSETDA ONSETDT ONSETMO ONSETYR OTHSP2 OTHSP2 OUTCOME REASON2 REASON2 RELAT SEVERE SICKLE STOPDA STOPDT STOPMO STOPYR TREAT TREAT
Death
Disability Status
Hospitalization
Medical Event
Serious Adverse Event	DEVISAE SAE

Medical History (0)

Mental Health (0)

Musculoskeletal (0)

Neurodevelopmental (0)

Neurologic (0)

Nutritional and Metabolic (0)

Ocular (0)

Oral (0)

Pain (38)

Data Element	Variables
Abdominal Pain
General Pain	OVERALL OVERALL OVERALL OVERALL PAIN1 PAIN1 PAIN1 PAIN1 PAIN2 PAIN2 PAIN2 PAIN2 PAIN3 PAIN3 PAIN3 PAIN3 PAIN4 PAIN4 PAIN4 PAIN4 PAIN5 PAIN5 PAIN5 PAIN5 SCALE SCALE SCALE SCALE THORAC THORAC THORAC THORAC
Headache
Management
Pain Attack	CLINIC CLINIC HOME HOME PAIN PAIN
Skeletal and Joint Pain

Reproductive (1)

Data Element	Variables
Birth Outcome
Gestational Age
Menstruation
Pregnancy	EXCL8
Reproductive Behavior

Respiratory (45)

Data Element	Variables
Acute Chest Syndrome	ACS ACSUK EXCL3 INCL3 INCL3A INCL3B INCL3C INCL3D INCL3E INCL4 INCL4A INCL4B INCL4C INCL4D INCL4E INCL4NW SEVERE
Asthma	ASTHMA
Lung Disease	EXCL10
Other Respiratory Problem	EXCL6 HYPOX HYPOX HYPOXDA HYPOXDT HYPOXHR HYPOXHR HYPOXMI HYPOXMI HYPOXMO HYPOXTM HYPOXTM HYPOXYR MUSC MUSC MUSC MUSC NASAL NASAL NASAL NASAL NOVALUE RETRAC RETRAC RETRAC RETRAC

Skin (0)

Sleep (0)

Surgery History (0)

Demographics (13)

Data Element	Variables
Address
Age	DOBDA DOBDT DOBMO DOBYR
Ethnic Group	ETHNIC
Gender	GENDER
Language
National Origin
Nuclear Family
Race	OTHSP RACE1 RACE2 RACE3 RACE4 RACE5 RACE6

Social Determinants of Health (SDoH) (0)

Socioeconomic Status (0)

Environmental Exposure (0)

Exposure (0)

Health Care (29)

Acute Care Utilization (14)

Data Element	Variables
Facility Type
Provider Type
Quality of Care
Visit	EREASN1 EREASN2 ERV1S ERV2S ERVADDA ERVADDT ERVADMO ERVADYR ERVDSDA ERVDSDT ERVDSMO ERVDSYR ERVISIT ERVISIT

Healthcare utilization (0)

Health Services (0)

Hospitalization (15)

Data Element	Variables
Final Diagnosis
Hospitalization	REASON1 REASON2 ADMITYR DAYNUM DISCDA DISCDT DISCMO DISCYR ADMITDA ADMITDT ADMITMO HSPVST HSPVST REAS1S REAS2S
ICU

SCD Management (0)

Imaging (8)

Angiogram (0)

CT Scan (0)

Echocardiogram (0)

Electrocardiogram (ECG) (0)

Electrodiagnosis (0)

General Imaging (0)

MRI/MRA (0)

Nuclear Medicine Imaging (0)

PET scan (0)

Transcranial Doppler (TCD) (0)

Ultrasound (0)

X-Ray (8)

Data Element	Variables
Abdomen
Biliary Tract
Chest	CHEST CHESTYN CIFYES CPULYN PULYN PULYN2 IFYES IFYES2
Extremities
Gallbladder
Liver
Skull

Parent/Caretaker (0)

Demographics (0)

Psychosocial (0)

Quality of Life (0)

General Health (0)

Pain (0)

Patient Functioning (0)

SCD (0)

Tests (113)

Biopsy (0)

Blood (40)

Data Element	Variables
Blood Differential Test
Blood Gases	SPO2NA SPO2NA SPO2NA SPO2ND SPO2VAL SPO2VAL SPO2VAL SPO2VAL
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count	ABRETIC ABRETIC ABRETIC ABRETIC HCT HCT HCT HCT HGB HGB HGB HGB MCV MCV MCV MCV PLATE PLATE PLATE PLATE RBC RBC RBC RBC RETICPT RETICPT RETICPT RETICPT WBC WBC WBC WBC
Comprehensive Metabolic Panel (CMP)
Enzyme
General
Hemoglobin Electrophoresis
Iron

Cardiovascular (0)

Genitourinary (0)

Immune (0)

Microbiology Culture (25)

Data Element	Variables
Blood Culture	BCND CCONTAM CONTAM CORG1 CORG2 CORG3 CORG4 CORG5 CORG6 CORG7 CORG8 CORG9 CORGSP CRESULT ORG1 ORG2 ORG3 ORG4 ORG5 ORG6 ORG7 ORG8 ORG9 ORGSP RESULT
Microbiology Culture

Musculoskeletal (0)

Neurologic (0)

Ocular (0)

Other (0)

Physical Exam (27)

Data Element	Variables
Abdomen
Anthropometrics	WEIGHT WEIGHT
Cardiovascular
Extremities
General
Liver
Reproductive
Respiratory
Spleen
Vital signs	DIA DIA DIA DIA1 DIA2 O2SAT RATE RATE RATE RESP RESP RESP RESPRAT RESPRAT RESPRAT RESPRAT SYS SYS SYS SYS1 SYS2 TEMP TEMP TEMP TEMP

Reproductive (5)

Data Element	Variables
Pregnancy	TYPE REASON RESULT RSNOTS PREGND

Respiratory (16)

Data Element	Variables
Pulmonary Function Test	CORHGB1 CORHGB2 DLCO1 DLCO2 FEF1 FEF2 FEV1 FEV2 FEVFVC1 FEVFVC2 FVC1 FVC2 ND1 ND2 PEFR1 PEFR2
Respiratory Test

Therapeutics (103)

Medication (67)

Data Element	Variables
Antibiotics	CTHERAP THERAPY
Asthma
Blood Medication History
Cardiovascular
Compliance	INCL5
Current Medication	DOSE EXCL4 EXCL9 INDICAT MEDICAT ONGOING PREXIST ROUTE ROUTSP STARTDA STARTDT STARTHR STARTMI STARTMO STARTTM STARTYR STOPDA STOPDT STOPHR STOPMI STOPMO STOPTM STOPYR UNIT UNITSP
Depression Medication History
Hydroxyurea
Medication	COMM COMM DOSE DOSE DOSEDA DOSEDA DOSEDT DOSEDT DOSEHR DOSEHR DOSEMI DOSEMI DOSEMO DOSEMO DOSERSP DOSETM DOSETM DOSEYR DOSEYR EXCL5 MISSED OVERDOS ROUTE
Neurologic Medication History
Pain	ROUTE ROUTESP OPIOID OPIOID2 OPSP OPSP2 BOLUS COMM COMM2 DAY DAY DOSE DOSE INFU UNIT UNITSP
SCD Medication
Sildenafil
Supplements

Surgery (0)

Transfusion (5)

Data Element	Variables
Blood Transfusion	NUMSIMP STRANSP TRAN TRANTYP
Chronic Transfusion	EXCL7
Transfusion Complications

Transplantation (0)

Treatment (31)

Data Element	Variables
Oxygen	NOSUPO2 SUPO2 SUPO2 SUPO2 SUPO2 SUPO2 SUPO2 SUPO2 SUPO2DA SUPO2DA SUPO2DT SUPO2DT SUPO2HR SUPO2HR SUPO2HR SUPO2MI SUPO2MI SUPO2MI SUPO2MO SUPO2MO SUPO2TM SUPO2TM SUPO2TM SUPO2YR SUPO2YR VENTSUP VENTSUP VENTSUP VENTSUP YESO2
Treatment	EXCL2

Study Publications

Tapered oral dexamethasone for the acute chest syndrome of sickle cell disease

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Functional Exercise Capacity (0)

Mental Health (0)

Neurodevelopment (0)

Neuropsychological (0)

Pain (0)

Physical Exam (0)

Psychosocial (0)

Quality of Care (0)

Quality of Life (0)

Sleep (0)

Technology Support (0)

Study Documentation Select All	1. Dexamethasone_metadata_07Nov2007 2. ACS-Dex Protocol ver 7.0 29JAN2008 - CLEAN 3. SIMVersion-3.0
Forms Select All	1. aCRF_Dexamethasone_28SEP2007_Unique 2. F1_Inclusion-Criteria 3. F2_Exclusion-Criteria 4. F3_Demographics 5. F4_Pregnancy-Test 6. F5_ACS-Assessment 7. F6_Study_Enrollment-Hematology_Labs 8. F7_ACS_Assessment 9. F8_Hematology_Labs 10. F9_Daily_Assessments 11. F10_Hospital_Discharge 12. F11_Follow-up_I-ACS_Assessment 13. F12_Follow-up_I_Assessment 14. F13_Follow-up_I-Interval_Health_History 15. F14_Follow-up_I-Hematology_Labs 16. F15_Follow-up_II-ACS_Assessment 17. F16_Follow-up_II_Assessment 18. F17_Follow-up_II-Interval_Health_History 19. F18_Follow-up_II-Respiratory_Assessments 20. F19_Follow-up_II-Hematology_Labs 21. F20_Study_Completion 22. F21_Study_Drug_Hospital_Log 23. F22_Study_Drug_Home_Record 24. F23_Concomitant_Medications 25. F24_Adverse_Experiences 26. F25_Chest_Radiograph 27. F26_Blood_Culture 28. F27_Opioid_Analgesia 29. F28_Protocol_Deviation

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