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Sickle Cell Disease and CardiovAscular Risk - Red Cell Exchange Trial (SCD-CARRE)

Study acronym: SCD-CARRE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion moved earlier from Jul 31, 2026 to May 11, 2026 Completion pushed from Jul 31, 2026 to Oct 31, 2026v20 Show 1 more changeShow less
    • Completion pushed from Jul 31, 2026 to Oct 31, 2026
  2. Primary and study completion pushed from May 31, 2026 to Jul 31, 2026v19
  3. Re-verified, no change to tracked fieldsv18
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 160 to confirmed 173 · Secondary endpoints: 16 to 17 · Site details revised at 23 of 23 sitesv17 Show 3 more changesShow less
    • Enrollment target: estimated 160 to confirmed 173
    • Secondary endpoints: 16 to 17
    • Site details revised at 23 of 23 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 150 to 160 Eligibility criteria expanded, about 15 wordsv16 Show 1 more changeShow less
    • Eligibility criteria expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

Show 14 earlier versionsHide 14 earlier versions
  1. Lead sponsor: Gladwin, Mark, MD to University of Pittsburgh Primary completion date: Dec 31, 2025 to May 31, 2026 · Completion date: Apr 30, 2026 to May 31, 2026v15 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2025 to May 31, 2026
    • Completion date: Apr 30, 2026 to May 31, 2026
  2. Site details revised at 1 of 23 sitesv14
  3. Study sites: 22 to 23v13
  4. Study sites: 20 to 22 Eligibility criteria expanded, about 86 words · Secondary endpoints: 20 to 16v12 Show 2 more changesShow less
    • Eligibility criteria expanded, about 86 words
    • Secondary endpoints: 20 to 16

    See this version in full on ClinicalTrials.gov ↗

  5. Lead sponsor: Mark Gladwin to Gladwin, Mark, MD Site contacts updated at 1 of 20 sitesv11 Show 1 more changeShow less
    • Site contacts updated at 1 of 20 sites
  6. Eligibility criteria expanded, about 31 words Site details revised at 4 of 20 sitesv10 Show 1 more changeShow less
    • Site details revised at 4 of 20 sites

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 16 to 20v9
  8. Study sites: 15 to 16v8
  9. Study sites: 14 to 15v7
  10. Study sites: 11 to 14v6
  11. Study sites: 9 to 11v5
  12. Study sites: 1 to 9 Eligibility criteria shortened, about 34 words · Secondary endpoints: details revised at 1 of 20 entriesv4 Show 2 more changesShow less
    • Eligibility criteria shortened, about 34 words
    • Secondary endpoints: details revised at 1 of 20 entries

    See this version in full on ClinicalTrials.gov ↗

  13. Start date changed from estimate of Mar 2020 to Feb 26, 2020v3
  14. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 1, 2020 to Mar 2020 · Study site revisedv2 Show 2 more changesShow less
    • Start date: Jan 1, 2020 to Mar 2020
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care.
Trial Details
NCT Number NCT04084080
Lead Sponsor University of Pittsburgh
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Sickle Cell Disease
Enrollment 173 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov