{
  "checked_date": "2026-10-31",
  "scope": "ClinicalTrials.gov records for Hemopure/HBOC-201/glutamer-250; not all clinical studies ever conducted",
  "record_count": 9,
  "counts_by_study_type": {
    "INTERVENTIONAL": 6,
    "EXPANDED_ACCESS": 3
  },
  "counts_by_status": {
    "TERMINATED": 1,
    "UNKNOWN": 2,
    "COMPLETED": 2,
    "ENROLLING_BY_INVITATION": 1,
    "NO_LONGER_AVAILABLE": 3
  },
  "records": [
    {
      "nct_id": "NCT00300040",
      "official_title": "Phase II, Multi-Center,Single-Blind,Placebo-Controlled Study,Evaluating Safety & Feasibility of HBOC-201 (Wound Healing Patients With Peripheral Vascular Disease & Undergoing Lower Limb Amputation Due to Critical Lower Limb Ischemia",
      "protocol_id": "BIOSA001/BIOEU001",
      "product": "Hemopure / HBOC-201 / hemoglobin glutamer-250 (bovine)",
      "participant_species": "Human",
      "minimum_age": "18 Years",
      "maximum_age": "75 Years",
      "study_type": "INTERVENTIONAL",
      "phase": [
        "PHASE2"
      ],
      "allocation": "RANDOMIZED",
      "intervention_model": "PARALLEL",
      "masking": "SINGLE",
      "status": "TERMINATED",
      "last_known_status": null,
      "enrollment_count": 16,
      "enrollment_type": "ACTUAL",
      "last_update_posted": "2008-05-16",
      "status_verified_date": "2008-05",
      "why_stopped": "Very slow enrollment.Study entry criteria not in line w/local standards of care",
      "lead_sponsor": "Biopure Corporation",
      "has_posted_structured_results": false,
      "official_url": "https://clinicaltrials.gov/study/NCT00300040",
      "official_api_url": "https://clinicaltrials.gov/api/v2/studies/NCT00300040",
      "brief_title": "Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia"
    },
    {
      "nct_id": "NCT00301483",
      "official_title": "A Single-Center, Study to Evaluate the Safety and Tolerability of Hemoglobin-Based Oxygen Carrier-201 (HBOC 201) in Trauma Subjects. (Phase II - Safety and Tolerability)",
      "protocol_id": "HEM-0125",
      "product": "Hemopure / HBOC-201 / hemoglobin glutamer-250 (bovine)",
      "participant_species": "Human",
      "minimum_age": "18 Years",
      "maximum_age": "65 Years",
      "study_type": "INTERVENTIONAL",
      "phase": [
        "PHASE2"
      ],
      "allocation": "RANDOMIZED",
      "intervention_model": "CROSSOVER",
      "masking": "SINGLE",
      "status": "UNKNOWN",
      "last_known_status": "RECRUITING",
      "enrollment_count": 53,
      "enrollment_type": "ESTIMATED",
      "last_update_posted": "2008-03-06",
      "status_verified_date": "2008-02",
      "why_stopped": null,
      "lead_sponsor": "Biopure Corporation",
      "has_posted_structured_results": false,
      "official_url": "https://clinicaltrials.gov/study/NCT00301483",
      "official_api_url": "https://clinicaltrials.gov/api/v2/studies/NCT00301483",
      "brief_title": "A Single Site Safety and Tolerability Study of HBOC-201 in Trauma Subjects"
    },
    {
      "nct_id": "NCT00301535",
      "official_title": "Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)",
      "protocol_id": "BIOEU003",
      "product": "Hemopure / HBOC-201 / hemoglobin glutamer-250 (bovine)",
      "participant_species": "Human",
      "minimum_age": "18 Years",
      "maximum_age": "80 Years",
      "study_type": "INTERVENTIONAL",
      "phase": [
        "PHASE2"
      ],
      "allocation": "NON_RANDOMIZED",
      "intervention_model": "PARALLEL",
      "masking": "NONE",
      "status": "UNKNOWN",
      "last_known_status": "RECRUITING",
      "enrollment_count": 60,
      "enrollment_type": "ESTIMATED",
      "last_update_posted": "2008-05-16",
      "status_verified_date": "2008-05",
      "why_stopped": null,
      "lead_sponsor": "Biopure Corporation",
      "has_posted_structured_results": false,
      "official_url": "https://clinicaltrials.gov/study/NCT00301535",
      "official_api_url": "https://clinicaltrials.gov/api/v2/studies/NCT00301535",
      "brief_title": "A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery"
    },
    {
      "nct_id": "NCT00317512",
      "official_title": "A Multi-Center,Randomized,Double-Blind,Placebo-Controlled,Dose Finding Pilot Study, to Evaluate Safety/Feasibility of HBOC-201 in Elective Percutaneous Coronary Revascularization of Subjects With Acute Coronary Syndromes",
      "protocol_id": "COR-0001",
      "product": "Hemopure / HBOC-201 / hemoglobin glutamer-250 (bovine)",
      "participant_species": "Human",
      "minimum_age": "18 Years",
      "maximum_age": "75 Years",
      "study_type": "INTERVENTIONAL",
      "phase": [
        "PHASE2"
      ],
      "allocation": "RANDOMIZED",
      "intervention_model": "FACTORIAL",
      "masking": "TRIPLE",
      "status": "COMPLETED",
      "last_known_status": null,
      "enrollment_count": 45,
      "enrollment_type": "ACTUAL",
      "last_update_posted": "2008-05-16",
      "status_verified_date": "2008-05",
      "why_stopped": null,
      "lead_sponsor": "Biopure Corporation",
      "has_posted_structured_results": false,
      "official_url": "https://clinicaltrials.gov/study/NCT00317512",
      "official_api_url": "https://clinicaltrials.gov/api/v2/studies/NCT00317512",
      "brief_title": "Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization"
    },
    {
      "nct_id": "NCT00479895",
      "official_title": "Phase II, Open-Label Study in the Catheterization Laboratory Setting to Challenge the Concept That HBOC-201 Administration Might Improve Myocardial 'Oxygenation' and Myocardial Function at the Moment of (Brief) Coronary Occlusion",
      "protocol_id": "COR-0002",
      "product": "Hemopure / HBOC-201 / hemoglobin glutamer-250 (bovine)",
      "participant_species": "Human",
      "minimum_age": "18 Years",
      "maximum_age": "80 Years",
      "study_type": "INTERVENTIONAL",
      "phase": [
        "PHASE2"
      ],
      "allocation": "RANDOMIZED",
      "intervention_model": "CROSSOVER",
      "masking": "SINGLE",
      "status": "COMPLETED",
      "last_known_status": null,
      "enrollment_count": 5,
      "enrollment_type": "ACTUAL",
      "last_update_posted": "2008-05-30",
      "status_verified_date": "2008-05",
      "why_stopped": null,
      "lead_sponsor": "Biopure Corporation",
      "has_posted_structured_results": false,
      "official_url": "https://clinicaltrials.gov/study/NCT00479895",
      "official_api_url": "https://clinicaltrials.gov/api/v2/studies/NCT00479895",
      "brief_title": "Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization"
    },
    {
      "nct_id": "NCT01881503",
      "official_title": "Expanded Access Protocol for the Treatment Use of HBOC-201",
      "protocol_id": "E-12-454",
      "product": "Hemopure / HBOC-201 / hemoglobin glutamer-250 (bovine)",
      "participant_species": "Human",
      "minimum_age": "18 Years",
      "maximum_age": "80 Years",
      "study_type": "INTERVENTIONAL",
      "phase": [
        "NA"
      ],
      "allocation": "NA",
      "intervention_model": "SINGLE_GROUP",
      "masking": "NONE",
      "status": "ENROLLING_BY_INVITATION",
      "last_known_status": null,
      "enrollment_count": 50,
      "enrollment_type": "ESTIMATED",
      "last_update_posted": "2025-04-13",
      "status_verified_date": "2021-08",
      "why_stopped": null,
      "lead_sponsor": "Englewood Hospital and Medical Center",
      "has_posted_structured_results": false,
      "official_url": "https://clinicaltrials.gov/study/NCT01881503",
      "official_api_url": "https://clinicaltrials.gov/api/v2/studies/NCT01881503",
      "brief_title": "Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia"
    },
    {
      "nct_id": "NCT02684474",
      "official_title": "Expanded Access Protocol Using HBOC-201 to Treat Patients With Life Threatening Anemia, for Whom Blood is Not an Option",
      "protocol_id": "IRB00090805",
      "product": "Hemopure / HBOC-201 / hemoglobin glutamer-250 (bovine)",
      "participant_species": "Human",
      "minimum_age": "18 Years",
      "maximum_age": "80 Years",
      "study_type": "EXPANDED_ACCESS",
      "phase": [],
      "allocation": null,
      "intervention_model": null,
      "masking": null,
      "status": "NO_LONGER_AVAILABLE",
      "last_known_status": null,
      "enrollment_count": null,
      "enrollment_type": null,
      "last_update_posted": "2025-10-23",
      "status_verified_date": "2025-10",
      "why_stopped": null,
      "lead_sponsor": "Johns Hopkins University",
      "has_posted_structured_results": false,
      "official_url": "https://clinicaltrials.gov/study/NCT02684474",
      "official_api_url": "https://clinicaltrials.gov/api/v2/studies/NCT02684474",
      "brief_title": "Expanded Access Protocol Using HBOC-201"
    },
    {
      "nct_id": "NCT02934282",
      "official_title": "Expanded Access Protocol Using HBOC-201",
      "protocol_id": "20160819",
      "product": "Hemopure / HBOC-201 / hemoglobin glutamer-250 (bovine)",
      "participant_species": "Human",
      "minimum_age": "18 Years",
      "maximum_age": "80 Years",
      "study_type": "EXPANDED_ACCESS",
      "phase": [],
      "allocation": null,
      "intervention_model": null,
      "masking": null,
      "status": "NO_LONGER_AVAILABLE",
      "last_known_status": null,
      "enrollment_count": null,
      "enrollment_type": null,
      "last_update_posted": "2024-12-20",
      "status_verified_date": "2024-12",
      "why_stopped": null,
      "lead_sponsor": "Mauricio Lynn",
      "has_posted_structured_results": false,
      "official_url": "https://clinicaltrials.gov/study/NCT02934282",
      "official_api_url": "https://clinicaltrials.gov/api/v2/studies/NCT02934282",
      "brief_title": "HBOC-201 Expanded Access Protocol for Life-threatening Anemia for Whom Allogeneic Blood Transfusion is Not an Option"
    },
    {
      "nct_id": "NCT03633604",
      "official_title": "An Expanded IND Access Investigation of HBOC-201 Infusion in Patients With Severe Acute Anemia Who Are Unable to Receive Red Blood Cell Transfusion",
      "protocol_id": "STUDY19070376",
      "product": "Hemopure / HBOC-201 / hemoglobin glutamer-250 (bovine)",
      "participant_species": "Human",
      "minimum_age": "18 Years",
      "maximum_age": "80 Years",
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      "intervention_model": null,
      "masking": null,
      "status": "NO_LONGER_AVAILABLE",
      "last_known_status": null,
      "enrollment_count": null,
      "enrollment_type": null,
      "last_update_posted": "2026-07-20",
      "status_verified_date": "2026-07",
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      "lead_sponsor": "Michael Boisen",
      "has_posted_structured_results": false,
      "official_url": "https://clinicaltrials.gov/study/NCT03633604",
      "official_api_url": "https://clinicaltrials.gov/api/v2/studies/NCT03633604",
      "brief_title": "Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia"
    }
  ],
  "query_audit": [
    {
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      "official_api_url": "https://clinicaltrials.gov/api/v2/studies?format=json&pageSize=100&countTotal=true&query.term=Oxyglobin",
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}
