Metadata Catalog

Study Detail

Study ID	1025
Name	Comprehensive Sickle Cell Centers' (CSCC) -HU-Mg
Contact Email	winfred.wang@stjude.org
Acronym	CSCC-HU-Mg
Period	2007 - 2009
Design	Clinical Trial
Study PI	Winfred Wang
Institution	RTI International
URL	https://clinicaltrials.gov/ct2/show/NCT00532883
CTGovID	https://clinicaltrials.gov/ct2/show/NCT00532883
Funding Agency	NHLBI
Grant Number	1U54HL070587-01

Overview	Hemoglobin (Hb) SC disease is characterized by dense red blood cells, but treatment approachesaimed at its pathophysiology have been limited in scope. Furthermore, combination drug therapy in sickle celldisease has not been adequately tested. We will examine two oral therapies, hydroxyurea and magnesium, givenby themselves and in combination and compare them to placebo in a double-blinded Phase II study to determinetheir efficacy in reducing red cell density in Hemoglobin SC in children and adults. We will also examine theireffects on other red cell characteristics and on the frequency of clinical vaso-occlusive events. To accomplishthis, 188 subjects will be assigned randomly to one of four treatment groups (see below) and followed for oneyear after beginning treatment.
Focus Areas	1. To compare the effectiveness of hydroxyurea (HU) alone, magnesium pidolate (Mg) alone,and hydroxyurea + Mg in combination, and placebo in reducing the density of HbSC erythrocytes. 2. To examine the effect of the individual and combination treatments on:• hematologic parameters and Hb F levels in HbSC disease;• other biologic measures of erythrocyte activity and red cell-endothelial interactions in HbSC disease;• and prevention of vaso-occlusive episodes in HbSC disease.Additionally, we will examine the safety of HU + Mg in combination.
Outcomes	1. The change-from-baseline density of hemoglobin SC red cells (percent of RBCs with densitygreater than 41 g/dL) measured 2 months after initiation of treatment. 2. Change-from-baseline in:• Standard hematologic parameters [hemoglobin level, mean cell volume (MCV), reticulocyte count, whiteblood cell count, platelet count, absolute neutrophil count (ANC)].• Hemoglobin S, C, and F levels.• Red cell metabolic studies: K-Cl co-transport activity, Gardos channel activity, Na-Mg exchanger activity,red cell cation content, intracellular Mg.• Plasma total Mg and ionized Mg (iMg) levels.• Adhesion studies to laminin, thrombospondin, and endothelial cells; expression of red cell receptors andphosphatidylserine; adhesive response to epinephrine.Also the frequency of clinical vaso-occlusive events (pain events, acute chest syndrome).

Data Location	RTI International
Biospecimen Available	Blood; DNA; Plasma; Serum; Urine;
Data Consent	Consent includes statement regarding confidentiality of records. Deidentified data may be used for continuing research.
Biospecimen Consent	Samples collected during the study will be deidentified; all samples will be destroyed at the end of the study.
Contact Consent	NA
Genomic Data	Yes

Age Range	5-99
No. Participants	44
Inclusion Criteria	1. Diagnosis of HbSC disease 2. Hemoglobin level between 8 and 12.5 g/dL 3. At least one vaso-occlusive event (e.g., pain, acute chest syndrome) in the 12 months prior to study entry. An episode of pain is defined as the occurrence of pain in the extremities, back, abdomen, chest, or head that lasts at least 2 hours; requires a visit to a hospital, emergency room, clinic, or provider's office; and is not explained except by SCD. Acute chest syndrome is defined as a new pulmonary infiltrate on a chest x-ray associated with a fever (greater than 38.5° C), tachypnea, wheezing, cough, or chest pain. 4. Regular compliance with comprehensive care 5. In a steady disease state and not experiencing an acute complication of SCD (i.e., no hospitalization, pain event, or episode of acute chest syndrome within the 1 month prior to study entry)
Exclusion Criteria	1. Previous transfusion with remaining hemoglobin A greater than 10% 2. Previous treatment with hydroxyurea within the last 3 months 3. Previous treatment with magnesium within the 3 months prior to study entry (including vitamins containing magnesium) 4. Poor compliance with previous treatment regimens 5. Liver dysfunction (SGPT greater than twice the upper limit of normal) within the 1 month prior to study entry 6. Kidney dysfunction (creatinine greater than or equal to 1.0 mg/dL for participants less than 18 years of age; greater than or equal to 1.2 mg/dL for participants 18 years of age or older) within the 1 month prior to study entry 7. Pregnant 8. Ten or more hospital admissions for pain in the 12 months prior to study entry 9. Daily use of narcotics 10. Treatment with any investigational drug in the 3 months prior to study entry 11. Less than 3% red blood cells with density greater than 41 g/dL (as measured by the ADVIA 120 system) 12. Positive HIV test 13. Other long-term illness or disorder other than SCD that could adversely affect performance in the study (e.g., tuberculosis)

Study Documentation Select All	1. 2007Dec13 CHAMPS Protocol 6.1 - Final 2. Study Summary 3. CSCC-HU-Mg-SIM-Individual-Docs 4. CSCC-HU-Mg-SIM-Subject-Binder
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Clinical status (46)

Behavior (0)

Blood (0)

Cancer (3)

Data Element	Variables
Cancer	CANCER CANPRS CANSPEC

Cardiovascular (1)

Data Element	Variables
Aneurysm
Cardiac Failure
Cardiovascular Problem	HYPER
Heart Problem

Digestive (0)

Endocrine (0)

Family MedHx (0)

General Health (0)

Genitourinary (1)

Data Element	Variables
Genitourinary Problem
Kidney Problem
Priapism	PRIAP
Renal Dialysis History

Immune (0)

Lymphatic (1)

Data Element	Variables
Sarcoidosis
Spleen Problem	SPLENIC

Medical Event (30)

Data Element	Variables
Adverse event	ACTION_HU ACTION_MG AE_ONSET_DAY AE_STOP_DAY AETEXT CRISIS DEATH DEHYDR DEHYDR_NEW DIARR DIARR_GRADE DIARR_NEW FATAL HEMTOX HEMTOX_NEW HEPTOX HEPTOX_NEW HOSPVIS OAESP OUTCOME PHYVIS RELATION RENTOX RENTOX_NEW SEVERE SOCN TEAE TRAE
Death
Disability Status
Hospitalization
Medical Event
Serious Adverse Event	EDVIS SERIOUS

Medical History (0)

Mental Health (0)

Musculoskeletal (2)

Data Element	Variables
Musculoskeletal Problem
Osteomyelitis
Osteonecrosis	HIP SHOLDR
Rheumatic Diseases

Neurodevelopmental (0)

Neurologic (1)

Data Element	Variables
Meningitis
Neurologic Event
Seizure
Stroke	STROKE
Transient Ischemic Attack

Nutritional and Metabolic (0)

Ocular (1)

Data Element	Variables
Ocular Problem
Sickle Retinopathy	RETIN

Oral (0)

Pain (3)

Data Element	Variables
Abdominal Pain	ABDOM ABDOM_NEW ABDOM_SEV
General Pain
Headache
Management
Pain Attack
Skeletal and Joint Pain

Reproductive (0)

Respiratory (1)

Data Element	Variables
Acute Chest Syndrome	ACS
Asthma
Lung Disease
Other Respiratory Problem

Skin (2)

Data Element	Variables
Skin Problem	LESION ULCER

Sleep (0)

Surgery History (0)

COVID-19 (0)

Diagnosis (0)

Impact (0)

Treatment (0)

Vaccination (0)

Demographics (3)

Data Element	Variables
Address
Age	AGE_GROUP
Ethnic Group
Gender	GENDER
Language
National Origin
Nuclear Family
Race	RACE

Social Determinants of Health (SDoH) (0)

Socioeconomic Status (0)

Environmental Exposure (0)

Exposure (0)

Health Care (1)

Acute Care Utilization (1)

Data Element	Variables
Facility Type	PAINHOME
Provider Type
Quality of Care
Visit

Healthcare utilization (0)

Health Services (0)

Hospitalization (0)

SCD Management (0)

Imaging (1)

Angiogram (0)

Catheterization (0)

CT Scan (0)

Echocardiogram (0)

Electrocardiogram (ECG) (0)

Electrodiagnosis (0)

General Imaging (1)

Data Element	Variables
General Imaging	NEURO

MRI/MRA (0)

Nuclear Medicine Imaging (0)

PET scan (0)

Transcranial Doppler (TCD) (0)

Ultrasound (0)

X-Ray (0)

Parent/Caretaker (0)

Demographics (0)

Psychosocial (0)

Quality of Life (0)

General Health (0)

Pain (0)

Patient Functioning (0)

SCD (0)

Tests (338)

Biopsy (0)

Blood (331)

Data Element	Variables
Blood Differential Test	ANC RET
Blood Gases	BASECHLOR_CAT BASECO2 CHG_CO2 CO2 CO2_CAT CO2_HIGH PCHG_CO2 WRSTCO2_CAT
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count	A_ABHRETI A_ABLRETI A_ABMRETI A_ABRET2 A_ABRETIC A_CBCCH A_CBCCHCM A_CBCHCT A_CBCHDW A_CBCHGB A_CBCMCH A_CBCMCHC A_CBCMCV A_CBCMPV A_CBCRBC A_CBCRDW A_CBCWBC A_RETIC ANC_CAT ANC_HIGH ANC_LOW ARC ARC_CAT ARC_HIGH ARC_LOW BASEA_ABHRETI BASEA_ABLRETI BASEA_ABMRETI BASEA_abret2 BASEA_ABRETIC BASEA_ADCELLS BASEA_CBCCH BASEA_CBCCHCM BASEA_CBCHCT BASEA_CBCHDW BASEA_CBCHGB BASEA_CBCMCH BASEA_CBCMCHC BASEA_CBCMCV BASEA_CBCMPV BASEA_CBCRBC BASEA_CBCRDW BASEA_CBCWBC BASEA_HBHBA BASEA_HBHBA2 BASEA_HBHBC BASEA_HBHBF BASEA_HBHBS BASEA_HRETIC BASEA_LRETIC BASEA_MRETIC BASEA_RBCHYPE BASEA_RBCHYPO BASEA_RBCMACR BASEA_RBCMICR BASEA_RETIC BASEANC BASEANC_CAT BASEARC BASEARC_CAT BASEHCT BASEHCT_CAT BASEHGB BASEHGB_CAT BASEMCHC BASEMCHC_CAT BASEMCV BASEMCV_CAT BASEPLT BASEPLT_CAT BASERBC BASERBC_CAT BASERET BASEWBC BASEWBC_CAT CHG_A_ABHRETI CHG_A_ABLRETI CHG_A_ABMRETI CHG_A_ABRETIC CHG_A_ADCELLS CHG_A_CBCCH CHG_A_CBCCHCM CHG_A_CBCHCT CHG_A_CBCHDW CHG_A_CBCHGB CHG_A_CBCMCH CHG_A_CBCMCHC CHG_A_CBCMCV CHG_A_CBCMPV CHG_A_CBCRBC CHG_A_CBCRDW CHG_A_CBCWBC CHG_A_HBHBA CHG_A_HBHBA2 CHG_A_HBHBC CHG_A_HBHBF CHG_A_HBHBS CHG_A_HRETIC CHG_A_LRETIC CHG_A_MRETIC CHG_A_RBCHYPE CHG_A_RBCHYPO CHG_A_RBCMACR CHG_A_RBCMICR CHG_A_RETIC CHG_HCT CHG_HGB CHG_MCHC CHG_MCV CHG_PLT CHG_RBC CHG_RET CHG_WBC HCT HCT_CAT HCT_HIGH HCT_LOW HGB HGB HGB_2 HGB_CAT HGB_HIGH HGB_LOW MCHC MCHC_CAT MCHC_HIGH MCHC_LOW MCV MCV_CAT MCV_HIGH MCV_LOW PCHG_A_ABHRETI PCHG_A_ABLRETI PCHG_A_ABMRETI PCHG_A_ABRETIC PCHG_A_ADCELLS PCHG_A_CBCCH PCHG_A_CBCCHCM PCHG_A_CBCHCT PCHG_A_CBCHDW PCHG_A_CBCHGB PCHG_A_CBCMCH PCHG_A_CBCMCHC PCHG_A_CBCMCV PCHG_A_CBCMPV PCHG_A_CBCRBC PCHG_A_CBCRDW PCHG_A_CBCWBC PCHG_A_HBHBA PCHG_A_HBHBA2 PCHG_A_HBHBC PCHG_A_HBHBF PCHG_A_HBHBS PCHG_A_HRETIC PCHG_A_LRETIC PCHG_A_MRETIC PCHG_A_PLATOTL PCHG_A_RBCHYPE PCHG_A_RBCHYPO PCHG_A_RBCMACR PCHG_A_RBCMICR PCHG_A_RETIC PCHG_ANC PCHG_HCT PCHG_HGB PCHG_MCHC PCHG_MCV PCHG_PLT PCHG_RBC PCHG_RET PCHG_WBC PLT PLT_CAT PLT_HIGH PLT_LOW RBC RBC_CAT RBC_HIGH RBC_LOW RBCHYP RET_CAT RET_HIGH RET_LOW WBC WBC_CAT WBC_HIGH WBC_LOW WRSTANC_CAT WRSTARC_CAT WRSTHCT_CAT WRSTHGB_CAT WRSTMCHC_CAT WRSTMCV_CAT WRSTPLT_CAT WRSTRBC_CAT WRSTRET_CAT WRSTWBC_CAT YHGBA
Comprehensive Metabolic Panel (CMP)	ALBUM ALBUM_CAT ALBUM_HIGH ALBUM_LOW ALKPH ALKPH_CAT ALKPH_HIGH ALKPH_LOW ALT ALT_CAT ALT_HIGH ALT_LOW BASEALBUM BASEALBUM_CAT BASEALKPH BASEALKPH_CAT BASEALT BASEALT_CAT BASEBUN BASEBUN_CAT BASECALC BASECALC_CAT BASECHLOR BASECO2_CAT BASECREAT BASECREAT_CAT BASEPOTAS BASEPOTAS_CAT BASERET_CAT BASESOD BASESOD_CAT BASETBILI BASETBILI_CAT BASETPROT BASETPROT_CAT BCAM BUN BUN_CAT BUN_HIGH BUN_LOW CALC CALC_CAT CALC_HIGH CALC_LOW CHG_ALBUM CHG_ALKPH CHG_ALT CHG_ANC CHG_BUN CHG_CALC CHG_CHLOR CHG_CREAT CHG_POTAS CHG_SOD CHG_TBILI CHG_TPROT CHLOR CHLOR_CAT CHLOR_HIGH CHLOR_LOW CO2_LOW CREAT CREAT_CAT CREAT_HIGH CREAT_LOW CRITER LDH LDH_CAT LDH_HIGH LDH_LOW PCHG_ALBUM PCHG_ALKPH PCHG_ALT PCHG_BUN PCHG_CALC PCHG_CHLOR PCHG_CREAT PCHG_POTAS PCHG_SOD PCHG_TBILI PCHG_TPROT POTAS POTAS_CAT POTAS_HIGH POTAS_LOW SOD SOD_CAT SOD_HIGH SOD_LOW TBILI TBILI_CAT TBILI_HIGH TBILI_LOW TPROT TPROT_CAT TPROT_HIGH TPROT_LOW WRSTALBUM_CAT WRSTALKPH_CAT WRSTALT_CAT WRSTBUN_CAT WRSTCALC_CAT WRSTCHLOR_CAT WRSTCREAT_CAT WRSTPOTAS_CAT WRSTSOD_CAT WRSTTBILI_CAT WRSTTPROT_CAT
Enzyme	BASELDH BASELDH_CAT CHG_LDH PCHG_LDH WRSTLDH_CAT
General
Hemoglobin Typing	A_HBHBA A_HBHBA2 A_HBHBC A_HBHBF A_HBHBS A_HRETIC ELECND ELECTRO FLAG_A
Iron	FPERC

Cardiovascular (0)

Genitourinary (3)

Data Element	Variables
Genitourinary Test
Urine Test	MCRORBC MCROWBC PROTEIN

Immune (0)

Microbiology Culture (0)

Musculoskeletal (0)

Neurologic (0)

Ocular (0)

Other (0)

Physical Exam (4)

Data Element	Variables
Abdomen
Anthropometrics	WEIGHT_TRUNC
Cardiovascular
Extremities
General	PHEXND
Liver
Reproductive
Respiratory
Spleen	SPLEEN SLPESP
Vital signs

Reproductive (0)

Respiratory (0)

Therapeutics (21)

Medication (19)

Data Element	Variables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication	CMED_START_DAY CMED_STOP_DAY INDICAT MEDIC MEDNAME
Depression Medication History
Hydroxyurea	DISC_ALL DISC_CHRONIC DISC_DECLINE DISC_HEPATIC DISC_INCREAS DISC_INGEST DISC_PULMNRY DISC_RENAL DISC_STROKE DISC_TOXICTY DISCAFV6 DISCB4V6 DISCONT DOSED
Medication
Neurologic Medication History
Pain
SCD Medication
Sildenafil
Supplements

Surgery (0)

Transfusion (2)

Data Element	Variables
Blood Transfusion	BTRANS HGBA
Chronic Transfusion
Transfusion Complications

Transplantation (0)

Treatment (0)

Study Publications

The effects of hydroxycarbamide and magnesium on haemoglobin SC disease: results of the multi-centre CHAMPS trial

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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)

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