Metadata Catalog
Natural History Data Resource

Working...

Study Detail

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.
Study Documentation
  Select All
   1. Dexamethasone_metadata_07Nov2007
   2. ACS-Dex Protocol ver 7.0 29JAN2008 - CLEAN
   3. SIMVersion-3.0
Forms
  Select All

Data ElementVariables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease GENOTYP
INCL2
Data ElementVariables
Aneurysm
Cardiac Failure
Cardiovascular Problem FLUID
HYPER
OTHSP
REASON
TREAT
Heart Problem
Data ElementVariables
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
Data ElementVariables
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
Data ElementVariables
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
Data ElementVariables
Birth Outcome
Gestational Age
Menstruation
Pregnancy EXCL8
Reproductive Behavior
Data ElementVariables
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
Data ElementVariables
Address
Age DOBDA
DOBDT
DOBMO
DOBYR
Ethnic Group ETHNIC
Gender GENDER
Language
National Origin
Nuclear Family
Race OTHSP
RACE1
RACE2
RACE3
RACE4
RACE5
RACE6
Data ElementVariables
Facility Type
Provider Type
Quality of Care
Visit EREASN1
EREASN2
ERV1S
ERV2S
ERVADDA
ERVADDT
ERVADMO
ERVADYR
ERVDSDA
ERVDSDT
ERVDSMO
ERVDSYR
ERVISIT
ERVISIT
Data ElementVariables
Final Diagnosis
Hospitalization DAYNUM
ADMITYR
DISCDA
DISCDT
DISCMO
DISCYR
ADMITDA
ADMITDT
ADMITMO
REAS1S
REAS2S
HSPVST
HSPVST
REASON1
REASON2
ICU
Data ElementVariables
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 Typing
Iron
Data ElementVariables
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
Data ElementVariables
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
Data ElementVariables
Pregnancy TYPE
PREGND
REASON
RESULT
RSNOTS
Data ElementVariables
Pulmonary Function Test CORHGB1
CORHGB2
DLCO1
DLCO2
FEF1
FEF2
FEV1
FEV2
FEVFVC1
FEVFVC2
FVC1
FVC2
ND1
ND2
PEFR1
PEFR2
Respiratory Test
Data ElementVariables
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 BOLUS
COMM
COMM2
DAY
DAY
DOSE
DOSE
INFU
ROUTE
ROUTESP
UNIT
UNITSP
OPIOID
OPIOID2
OPSP
OPSP2
SCD Medication
Sildenafil
Supplements
Data ElementVariables
Blood Transfusion NUMSIMP
STRANSP
TRAN
TRANTYP
Chronic Transfusion EXCL7
Transfusion Complications
Data ElementVariables
Discontinuation
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
Back to Study List