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Study Detail

Study ID 1009
Name Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia
Contact Email biolincc@imsweb.com
Acronym MSH
Period 1992-2008
Design Clinical Trial
Study PI Samuel Charache, Michael Terrin
Institution Multiple institutes
URL https://biolincc.nhlbi.nih.gov/studies/MSH/
CTGovID https://clinicaltrials.gov/ct2/show/NCT00000586
Funding Agency NHLBI
Grant Number UO1-HL45692, UO1-HL45696
Overview The primary objective of MSH was to determine whether or not treatment with hydroxyurea titrated to maximum tolerated doses would reduce the frequency of vaso-occlusive (painful) crises by at least 50%. The principal end point was the occurrence of a vaso-occlusive (painful) crisis, defined as pain not due to another cause, lasting at least four hours and requiring parenteral (or equivalent doses of oral narcotics)) narcotics or non-steroidal anti-inflammatory drugs for relief. Occurrences of chest syndrome were counted as crises. Pain due to chronic conditions such as ankle ulcers, osteomyelitis or aseptic necrosis of bone was not counted as crises. The secondary objectives investigated the correlations of fetal hemoglobin (HbF) levels and other patient or treatment characteristics with the occurrence of vaso-occlusive (painful) crises, and the effect of treatment on the quality of life.
Focus Areas 1. Correlations of fetal hemoglobin (HbF) levels and other patient or treatment characteristics with the occurrence of vaso-occlusive (painful) crises,
2. Effect of treatment on the quality of life
3. Crises which occur between two years after study entry and theend of follow-up for each patient.
4. In-patient crises.
5. The duration of hospitalization for each in-patient crisis.Records will also be kept of the occurrence of events which areclearly-defined, sickle-related and not painful crises including a. Death;
6. b. Stroke;
7. c. Development of any indication resulting in treatment withchronic transfusion therapy, such as stroke or pulmonaryfailure;
8. d. New osteomyelitis, proved by culture, with consistent abnormalitieson x-ray and/or bone scan;
9. e. Development of a new ankle ulcer or recurrence of a previouslyhealed ankle ulcer;
10. f.Infections;
11. g.Aseptic necrosis of bone.
Outcomes Occurrence of vaso-occlusive (painful) crisis [ Time Frame: Measured during the first 2 years a patient was enrolled in the study ]
Data Location BioLINCC, BioData Catalyst
Biospecimen Available Blood; DNA; Plasma; Serum;
Data Consent Data sharing via BioLINCC; By signing the consent, the patient gives the MSH investigators permission to get records from any medical facility attended during the study. Data may be shared with the National Heart, Lung, and Blood Institute, the manufacturer of hydroxyurea, or the U.S. Food and Drug Administration (FDA).
Biospecimen Consent Sample sharing via BIOLINCC; Genetic Use of Specimens Allowed
Contact Consent NA
Genomic Data No
Age Range 18-50
No. Participants 299
Inclusion Criteria 1. Men and women, ages 18 to 50, who had at least three emergency room visits or hospitalizations for sickle cell anemia during the year prior to recruitment.
2. Patients with greater than 20 crises per year were included.
3. Diagnosis of sickle cell anemia by gel electrophoresis conducted by a Core Laboratory.
4. Patients were required to successfully complete a 2 week “run-in” period comprised of two visits with baseline blood sample collections, completion of a two week diary and daily ingestion of a folic acid tablet.
Exclusion Criteria 1. They are unwilling to use contraception unless tubal ligation, hysterectomy or vasectomy has been performed (in the patient or partner(s)).
2. They are receiving prescriptions for more than 30 oxycodone capsules (or equivalent-see section 6.2) at a time from clinic personnel.
3. Creatinine is >1.7 mg/dL;
4. Transfusions have been received within 2 months of enrollment, or the patient is on a chronic transfusion program; or the patient is likely to begin chronic transfusion therapy in the next two years;
5. Active liver disease is present, as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>300 units or abnormal and increasing on serial samples;
6. There is a contraindication for potentially immunosuppressive therapy (HIV antibody testing is required for eligibility and a positive test will result in patient ineligibility);
7. Serum B12, ferritin or folate is abnormally low (patients are acceptable after treatment of deficiency states);
8. Hydroxyurea therapy has been or is currently being administered;
9. The patient is pregnant (tested for in all women before randomization) or breast-feeding;
10. S/ß0 thalassemia is known to be present;
11. The patient is receiving theophylline, androgen, estrogen, progestin (except for birth control), calcium channel blockers, danazol, or any other drug suspected to have an anti-sickling effect
12. The patient has a history of cerebrovascular accident (stroke) and has been on a chronic transfusion program
13. The patient has a history of congestive heart failure and has been on a chronic transfusion program
14. There has been failure to obtain informed consent
15. Hemoglobin-A greater than 15%.
Study Documentation
  Select All
   1. Clinical_Protocol
   2. EXT-1_Protocol
   3. PFU_Protocol
Forms
  Select All
   1. Form 01-Eligibility Screening Form I
   2. Form 02-Eligibility Screening Form II
   3. Form 03-Demographics
   4. Form 04-Medical Examination and History
   5. Form 05-Patient Diary
   6. Form 07-Gel Electrophoresis Report
   7. Form 08-Request for Enrollment
   8. Form 09-Treatment Initiation
   9. Form 11-Health Status Survey
   10. Form 12-Profile of Mood States and Ladder of Life
   11. Form 14-Patients Usual Residence
   12. Form 20-Follow-Up Visit
   13. Form 22-Missed Visit
   14. Form 23-Six-Month Medical Review and Examination
   15. Form 25-Medical Contact
   16. Form 30-Toxicity Review
   17. Form 31-Study Treatment Inventory
   18. Form 32-Initiation of Treatment Stop Order
   19. Form 33-Patient Contact for Treatment Stop Order Office
   20. Form 34-Patient Contact for Treatment Stop Order Clinic
   21. Form 35-Restart Treatment Order
   22. Form 37-Resume Tratement Order
   23. Form 39-Four-Week Telephone Follow-Up
   24. Form 44-Crisis Review Committee Event Classification Form
   25. Form 45-Death Notification
   26. Form 70 Study Close-Out for Investigators
   27. Form 73 Study Close-Out for Clinic Director
   28. Form 74-Study Close-Out for MSH Assistant Coordinator
   29. Form 75-Study Close-Out for Participant
   30. FU-Y1-5-Form 40-Patient Enrollment
   31. FU-Y1-5-Form 41-Demographics
   32. FU-Y1-5-Form 42-Health Status Questionnaire
   33. FU-Y1-5-Form 43-Medical Review and Examination
   34. FU-Y1-5-Form 44 Rev4-Hydroxyurea Review
   35. FU-Y1-5-Form 45-Protocol Review and Collection of Samples
   36. FU-Y1-5-Form 47-Chest X-Ray Summary
   37. FU-Y1-5-Form 48-ECG Summary
   38. FU-Y1-5-Form 49-Local Laboratory Report
   39. FU-Y1-5-Form 50-Patient Event
   40. FU-Y1-5-Form 55-Event Classification
   41. FU-Y6-9-Form 41-Demographics (1)
   42. FU-Y6-9-Form 42-Health Status Questionnaire
   43. FU-Y6-9-Form 43-Medical Review and Examination
   44. FU-Y6-9-Form 44-Hydroxyurea Review
   45. FU-Y6-9-Form 45-Protocol Review and Collection of Samples
   46. FU-Y6-9-Form 46-Offspring Review
   47. FU-Y6-9-Form 47-Chest X-Ray Summary
   48. FU-Y6-9-Form 48-ECG Summary
   49. FU-Y6-9-Form 49-Local Laboratory Report
   50. FU-Y6-9-Form 50-Patient Event
   51. FU-Y6-9-Form 66-Status of Patients Not Enrolled
   52. FU-Y6-9-Form 67-Arterial Blood Gases Analysis
   53. FU-Y6-9-Form 68-Spirometry Data Form
   54. FU-Y6-9-Form 69-HRCT of the Chest
   55. FU-Y6-9-Form 70-Patient Enrollment

Data ElementVariables
ASCQ-Me Emotional Impact
ASCQ-Me Social Functioning
Brief Resiliency Scale
NeuroQOL Fatigue
NIH Toolbox Loneliness
Pearlin Enhanced Self-Efficacy Scale
Profile of Mood States (POMS) ACTV_15V
ANXI_41T
BLUE_18D
BUSH_65F
CHEE_38V
DISC_32D
EDGE_16T
ENER_19V
EXHA_40F
FATG_29F
HELP_48D
HPLS_21D
LIVE_07V
MISR_36D
NERV_34T
PEP    56V
REST_27T
SAD    14D
TENS_02T
UNEA_26T
UNHA_05D
VIGO_63V
WEAR_49F
WORN_04F
WRTH_58D
PROMIS Anger
PROMIS Anxiety
PROMIS Depression
PROMIS Emotional Distress- Depression
PROMIS Emotional Support
PROMIS Fatigue
PROMIS Global Mental Health
PROMIS Satisfaction with Participation in Discretionary Social Activities
Data ElementVariables
ASCQ-Me SCD Medical History Checklist
ASCQ-Me Sexual Health
Child Health Questionnaire (CHQ)
Ladder of Life LOL5YA
LOL5YH
LOLNOW
Pediatric Quality of Life Inventory Child Report (ages 13-18)
Pediatric Quality of Life Inventory Child Report (ages 8-12)
Pediatric Quality of Life Inventory Parent Report for Child (ages 13-18)
Pediatric Quality of Life Inventory Parent Report for Child (ages 8-12)
PROMIS Global Health
PROMIS Global Physical Health
PROMIS Self-Efficacy for Managing Medications and Treatment
SF-36 Health Survey SF_1
SF_10A
SF_10B
SF_10C
SF_10D
SF_2
SF_3A
SF_3B
SF_3C
SF_3D
SF_3E
SF_3F
SF_3G
SF_3H
SF_3I
SF_3J
SF_4A
SF_4B
SF_4C
SF_4D
SF_5A
SF_5B
SF_5C
SF_6
SF_7
SF_8
SF_9A
SF_9B
SF_9C
SF_9D
SF_9E
SF_9F
SF_9G
SF_9H
SF_9I
SF_9J
UNDSTD
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