[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-to-severe-traumatic-brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-to-severe-traumatic-brain-injury":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100645090","comparing-sedatives-for-intracranial-pressure-control-in-traumatic-brain-injury-100645090",false,"NCT07678216","Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury","Effect of Propofol, Midazolam, and Dexmedetomidine on Intracranial Pressure and Clinical Outcomes in Patients With Moderate-to-Severe Traumatic Brain Injury Undergoing Urgent Neurosurgical Intervention","ICP-TBI","Inclusion Criteria:\n\n* Age ≥18 years\n\n  * Moderate to severe traumatic brain injury with post-resuscitation Glasgow Coma Scale (GCS) ≤12\n  * Undergone urgent neurosurgical intervention (craniotomy, craniectomy, or ICP monitor placement) within 24 hours of injury\n  * Admitted to ICU and expected to require continuous sedation\n  * Hemodynamically stable or stabilized (defined as MAP ≥65 mmHg with vasopressor requirement ≤0.1 mcg\u002Fkg\u002Fmin norepinephrine equivalent)\n  * Informed consent obtained from legally authorized representative\n\nExclusion Criteria:\n\n* The Relative refusal to participate in the research.\n* Known allergy or contraindication to propofol, midazolam, or dexmedetomidine\n* Pre-existing neurological disorders (epilepsy, prior stroke, brain tumors, dementia) that may interfere with outcome assessment\n* Severe hepatic dysfunction (Child-Pugh Class C) or acute liver failure\n* Severe renal dysfunction (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m² or requiring renal replacement therapy)\n* Pregnancy or breastfeeding\n* Hemodynamic instability requiring norepinephrine \\>0.1 mcg\u002Fkg\u002Fmin or equivalent vasopressor support\n* Heart rate \\\u003C50 bpm or second\u002Fthird-degree AV block without pacemaker (relative contraindication for dexmedetomidine)\n* Clinical determination of brain death or expected survival \\\u003C24 hours\n* Enrollment in another interventional trial\n* Severe polytrauma requiring ongoing surgical interventions that would interfere with protocol adherence","ALL","18 Years",{"count":20,"type":21},210,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adults with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention.\n\nThe main questions it aims to answer are:\n\n* Which sedative agent provides better control of intracranial pressure, assessed by optic nerve sheath diameter (ONSD), during the first 24 hours after neurosurgical intervention?\n* How do the three sedative agents compare in achieving target sedation depth, maintaining hemodynamic stability, and improving short-term clinical outcomes such as ICU mortality, duration of mechanical ventilation, and ICU length of stay?\n\nParticipants will be randomly assigned to receive propofol, midazolam, or dexmedetomidine for 24 hours of continuous sedation. Clinical, hemodynamic, and neurological outcomes will be assessed and compared among the three study groups.",[27],"Moderate-to-Severe Traumatic Brain Injury","NOT_YET_RECRUITING","2026-06-24",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":31,"type":21},{"date":35,"type":21},"2028-06-01",{"name":37,"class":38},"Aswan University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":39},"100629975","phase-4-effects-of-recombinant-human-growth-hormone-in-elderly-patients-with-moderate-to-severe-acute-brain-injury-gh-abi-rct-100629975","NCT07481656","Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT)","A Multicenter, Randomized Controlled Trial Evaluating Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury and Hypoalbuminemia","GH-ABI-RCT","Inclusion Criteria:\n\n1. Age ≥ 60 years, male or female.\n2. Hospitalized patients with acute brain injury (including traumatic brain injury, ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage) who had a Glasgow Coma Scale (GCS) score ≤ 12 at any time during hospitalization.\n3. Presence of hypoalbuminemia, defined as serum albumin \\\u003C 35 g\u002FL and\u002For prealbumin \\\u003C 200 mg\u002FL after admission.\n4. Willing and able to provide informed consent (by patient or legal representative).\n\nExclusion Criteria:\n\n1. Unstable vital signs, defined as deviations in body temperature, respiration, pulse, blood pressure, or oxygen saturation from normal ranges that, in the clinical judgment of the investigator, may jeopardize vital organ perfusion or indicate disease progression.\n2. Active malignancy or history of malignancy with a disease-free interval of less than 5 years.\n3. Diabetes mellitus with retinopathy.\n4. Any other condition deemed unsuitable for participation by the investigator (e.g., severe renal\u002Fhepatic dysfunction, active infection, known hypersensitivity to growth hormone, or participation in another interventional trial).","60 Years",{"count":50,"type":21},160,[52],"PHASE4","This study is a multicenter, randomized controlled trial aimed at evaluating the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients who have suffered moderate to severe acute brain injuries complicated by hypoproteinemia.\n\nEligible participants, aged 60 and older, with acute brain injuries and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.\n\nClinical data will be collected at baseline and weekly for four weeks. The primary outcome measure will be the change in plasma albumin levels from baseline to Week 2. Secondary outcome measures will include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rates, hemoglobin levels, length of hospital stays, length of intensive care unit stays, and functional outcomes.\n\nSafety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence that can help optimize nutritional support and rehabilitation strategies for elderly patients with acute brain injuries.This study is a multicenter, randomized controlled clinical trial designed to evaluate the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients with moderate to severe acute brain injury complicated by hypoproteinemia.\n\nEligible participants aged 60 years and older with acute brain injury and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.\n\nClinical data will be collected at baseline and weekly for four weeks. The primary outcome is the change in plasma albumin level from baseline to Week 2. Secondary outcomes include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rate, hemoglobin level, length of hospital stay, intensive care unit stay, and functional outcomes.\n\nSafety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence for optimizing nutritional support and rehabilitation strategies in elderly patients with acute brain injury.",[55,56],"Acute Brain Injuries","Moderate to Severe Traumatic Brain Injury",[58,59,60,56],"recombinant human growth hormone","rhGH","hypoproteinemia","2026-03-16",{"date":63,"type":32},"2026-03-19",{"date":65,"type":21},"2026-04-10",{"date":67,"type":21},"2028-10-30",{"name":69,"class":70},"Anhui Provincial Hospital","OTHER_GOV",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":39},"100520924","phase-2-ffp-in-traumatic-brain-injury-fit-brain-trial-100520924","NCT06062888","FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial","Multi-institutional Phase 2\u002F3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)","Inclusion Criteria:\n\n1. Male or female between the ages of 18 and 65 years\n2. Moderate to severe TBI: GCS 3-12\n3. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3).\n4. The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.\n\nExclusion Criteria:\n\n1. Persons with a known history of adverse reaction to plasma products.\n2. Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen.\n3. Persons who are currently incarcerated.\n4. Persons with inadequate venous access.\n5. Treatment cannot start within 1 hour of arrival at the hospital.\n6. The time of injury is unknown.\n7. Non-survivable injuries in the estimation of the attending trauma and\u002For neurosurgeon.\n8. Interfacility transfers\n9. Class 3 hemorrhagic shock\n10. Persons with known \"do not resuscitate\" orders prior to randomization\n11. Persons who refuse the administration of blood products\n12. Persons with a research \"opt out\" bracelet\n13. Persons who require FFP for any other indication (e.g., reversal of coagulopathy)","65 Years",{"count":80,"type":21},357,[82,83],"PHASE2","PHASE3","The goal of this clinical trial is to learn about treatment with fresh frozen plasma (FFP) in individuals with moderate to severe traumatic brain injury. The two main question\\[s\\]it aims to answer are:\n\n* Is the FFP treatment safe?\n* Does the FFP treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care free days, mortality, and hospital brain and physical function at discharge. Patients with moderate to severe TBI will randomly receive either:\n\n  * Standard of care treatment\n  * Standard of care treatment + 2 units of FFP. Researchers will compare participants receiving standard of care treatment to those receiving experimental fresh frozen plasma (FFP) treatment to see if the FFP is safe and beneficial to participant outcomes.",[56],[87,88,89,90],"TBI","Traumatic Brain Injury","Fresh frozen plasma","FFP","RECRUITING","2026-02-09",{"date":94,"type":32},"2026-02-11",{"date":96,"type":32},"2026-02-01",{"date":98,"type":21},"2029-06",{"name":100,"class":38},"Northwestern University"]