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Study Detail

Study ID 1027
Name Comprehensive Sickle Cell Centers' (CSCC) -Priapism
Contact Email Zora.Rogers@UTSouthwestern.edu
Acronym CSCC-Priapism
Period 2005 -2008
Design Observational cohort study
Study PI Zora Rogers
Institution RTI International
URL https://clinicaltrials.gov/ct2/show/NCT00300235
CTGovID https://clinicaltrials.gov/ct2/show/NCT00300235
Funding Agency NHLBI
Grant Number 1U54HL070587-01
Overview Priapism, a prolonged erection of the penis that may lead to impotence, is a specific type of painful crisis that commonly occurs in patients with sickle cell disease. The current treatment of priapism can be improved by comparing therapeutic strategies in prospective clinical trials, but first an assessment of the natural history of priapism is needed. This project will conduct an interview of 1,650 males with sickle cell disease in order to determine in which patients, how often, and under what circumstances priapism occurs.
Focus Areas 1. Enumerate the cross-sectional prevalence, demographics, and common clinical characteristics of priapism in males with sickle cell disease among the CSCC patient population.
2. Identify patients eligible for randomized clinical trials of promising secondary prevention strategies.
Outcomes 1. Enumeration of the prevalence of priapism in males with sickle cell anemia and sickle beta zero thalassemia.
2. Characterization of priapism in males with sickle cell anemia with reference to time of onset, duration of events, frequency of episodes, precipitating or associated activities, treatment modalities used, and outcome of treatments.
3. Descriptive comparison of the prevalence of priapism in males with sickle cell anemia to that described in older patients with other sickle hemoglobinopathies.
4. Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.
5. Enumeration of patients available for clinical trials of secondary prevention.
Data Location RTI International
Biospecimen Available N/A
Data Consent Consent includes Certificate of Confidentiality; consent includes statement regarding data deidentification.
Biospecimen Consent No sample
Contact Consent Yes, with permission on consent
Genomic Data No
Age Range 5-99
No. Participants 1464
Inclusion Criteria 1. Diagnosis of sickle cell anemia or sickle beta zero thalassemia, if 5 years of age or over OR
2. Diagnosis of sickle beta plus thalassemia or sickle hemoglobin C disease, if 15 years of age or over
3. Participant and/or parent or guardian must be able to communicate adequately with the interviewer
4. May participate if currently taking hydroxyurea, undergoing chronic transfusion, or participating in other research studies, including those involving treatments such as arginine, if all other inclusion criteria are met
Exclusion Criteria 1. Patient or parent/guardian declines participation.
2. Female.
3. Subject or parent/guardian unable to communicate adequately with the interviewer.
Study Documentation
  Select All
   1. Priapism Protocol V6.3 - Feb 10 2006 DATE CORRECTED
   2. Priapism_metadata_report_23May2008
   3. CSCC-Priapism_SIMv2
Forms
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Data ElementVariables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease DIAGNOS
Data ElementVariables
Genitourinary Problem IMPTNCE
INTRCRS
OVRNITE
WANTED
Kidney Problem ACUTE
ACUTEYR
CHRNC
Priapism AGEFRST
AGELAST
AGEONLY
AGOFRST
AGOLAST
AGOONLY
ALCOHOL
ASLEEP
ASPIRRG
ASPIRSP
AVGDAY
AVGHRS
AVGMIN
AVGUNK
AWAKE
AWARE
AWKASLP
B4TODAY
BREATHE
CAUSEUK
CAUSOT
CAUSOTS
CONSTIP
CTRANYS
CTRANYS
DURDAY
DURHRS
DURMIN
DURUNK
EPPRIOR
EPPSTYR
FLUIDSP
HYDRXYS
HYDRXYS
INFO
ISSUES
IVMEDSP
LASTDAY
LASTHRS
LASTMIN
LASTUNK
LONGDAY
LONGHRS
LONGMIN
LONGUNK
MEDS
MEDSSP
NOCAUSE
NOTREAT
NOTREAT
ORALSP
OTHTX
OTHTXSP
PAIN
PRIAP
PRIAPSM
PROBLEM
PSEUDO
SEXACT
SEXTHTS
SHRTDAY
SHRTHRS
SHRTMIN
SHRTUNK
SHUNTSP
SLEEP
START
TRANSP
TRNSFSN
WORST
YMOFRST
YMOLAST
YMOONLY
Renal Dialysis History DIALSIS
Data ElementVariables
Sarcoidosis
Spleen Problem SPLSQ
SPLSQYR
SPTMY
SPTMYYR
Data ElementVariables
Musculoskeletal Problem
Osteomyelitis
Osteonecrosis AVASC
BONE1
BONE1YR
BONE2
BONE2YR
BONE3
BONE3YR
Rheumatic Diseases
Data ElementVariables
Meningitis
Neurologic Event
Seizure
Stroke STRKE
STRKEYR
Transient Ischemic Attack
Data ElementVariables
Ocular Problem
Sickle Retinopathy SCELRET
SCELTST
Data ElementVariables
Abdominal Pain
General Pain
Headache
Management NARCTC
Pain Attack NUMPCRS
PNCRS
Skeletal and Joint Pain DACTL
DACTLYR
Data ElementVariables
Acute Chest Syndrome ACS3AGO
ACSLST3
CHEST
Asthma
Lung Disease PULMHYP
PULMTST
Other Respiratory Problem
Data ElementVariables
Skin Problem ULCER
ULCERYR
Data ElementVariables
Cardiovascular
Digestive
Genitourinary ASPIR
IMPLANT
NOPROC
SHUNT
SHUNTS
Lymphatic
Musculoskeletal
Ocular
Respiratory
Surgery History
Data ElementVariables
Address
Age DOBDA
DOBDT
DOBMO
DOBYR
Ethnic Group ETHNIC
Gender
Language
National Origin
Nuclear Family
Race AFRAMER
AMERIND
ASIAN
HAWAII
RACEOT
RACEOTS
WHITE
Data ElementVariables
Facility Type
Provider Type
Quality of Care
Visit DURING
Data ElementVariables
Final Diagnosis
Hospitalization HOSPYR
HOSPNME
HOSPOTH
ICU
Data ElementVariables
SCD Impact
SCD Management EXRCISE
FLUIDS
NOHOMET
REST
SHOWER
TXOTH
TXOTHS
URINATE
Data ElementVariables
Blood Differential Test
Blood Gases O2METH
O2METHS
O2SAT
O2SATDA
O2SATDT
O2SATMO
O2SATND
O2SATYR
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count HGBDA
HGBDT
HGBMO
HGBYR
HMGLBN
PLTDA
PLTDT
PLTLET
PLTMO
PLTYR
WBC
WBCDA
WBCDT
WBCMO
WBCYR
Comprehensive Metabolic Panel (CMP)
Enzyme
General
Hemoglobin Typing
Iron
Data ElementVariables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication
Depression Medication History
Hydroxyurea HYDRX
HYDRX
Medication MEDICIN
MEDNAME
MEDOT
MEDOTS
Neurologic Medication History
Pain CODEINE
IBUPRO
IVMED
ORALMED
SCD Medication
Sildenafil
Supplements
Data ElementVariables
Blood Transfusion TRAN
Chronic Transfusion CTRAN
CTRAN
Transfusion Complications
Data ElementVariables
Discontinuation
Oxygen
Treatment IVFLUID
Study Publications
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