[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07643493":3,"trial-entities:NCT07643493":124,"trial-summary:NCT07643493":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":42,"secondary_outcomes":50,"sex":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":15,"eligibility_criteria":86,"std_ages":98,"locations":101,"central_contacts":117,"overall_officials":121,"references":122,"see_also_links":123},"NCT07643493","104139","CleaRRAflow: Isotonic Solution vs. TPA for IVH Clearance","Utility of Continuous Intrathecal TPA Infusion for IVH Clearance With Ventricular Irrigation","NOT_YET_RECRUITING","2029-05-31","2026-07","2026-07-27","2026-08-03","David Dornbos","OTHER",false,"The study aims to investigate the effect of continuous tPA irrigation into the ventricles. Investigators believe it may be superior to the traditional every 8-hour bolus dosing and continuous isotonic solution irrigation alone. The protocol plans to analyze blood clearance and functional outcomes in the patients.","The study is a prospective randomized trial, evaluating the impact of continuous tissue plasminogen activator (TPA) infusion in the setting of intraventricular hemorrhage (IVH) with blinded endpoint adjudication. This trial will enroll adult patients admitted to the University of Kentucky with substantial IVH (primary IVH, intracranial hemorrhage \\[ICH\\] with IVH, and IVH secondary to subarachnoid hemorrhage \\[SAH\\]). Patients will undergo placement of an irrigating ventricular catheter as per standard of care. Ventricular catheter placement will occur in all patients at the discretion of the neurosurgical team. Procedural consent will proceed per institutional standard of care.\n\nFollowing irrigating ventricular catheter placement, irrigation and drainage will occur as per standard of care. Current use of intrathecal TPA for large-volume IVH burden is left to the discretion of the attending neurosurgeon. No standard of care exists as to its current clinical use, and it is often used, although sporadically in this patient population. Following device placement and initiation of irrigation, informed consent will be obtained by the neurosurgical research team. Following consent of either the patient or LAR, patients will be randomized in a 1:1 permuted block fashion to receive either irrigation alone or irrigation with continuous TPA infusion.\n\nInitiation of continuous TPA infusion should start within approximately 24 hours of drain placement. As per standard of care, daily head computed tomography (HCT) scans should be obtained. Irrigation rates of normal isotonic solution typically range from 30-90 cc\u002Fhour, depending on patient tolerance and intracranial pressure. Subjects randomized to the TPA arm will have the same range of irrigation rates, with the dose of TPA infused ranging from 4-6 mg\u002Fday.\n\nCSF should be collected from patients enrolled in the study following enrollment but prior to randomization and TPA initiation and then daily for up to 10 days. Collected CSF will then be assessed using MSD proteomics and ELISA assays to assess the inflammatory response, intercellular signaling, and breakdown products of hematoma and TPA. Patient outcomes (ICU length of stay, overall LOS, disposition, NIHSS scores, and functional outcomes) will be collected and assessed as available in the clinical record.",[19,20],"Tissue Plasminogen Activator","Intraventricular Brain Hemorrhage",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE4",{"count":27,"type":28},80,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Tissue Plasminogen Activator (tPA)","Tissue Plasminogen Activator (tPA) is infused through the ClearRRAflow catheter into the ventricular system to promote clearance of intraventricular hemorrhage.",[35],"Isotonic solution irrigation + TPA Infusion",{"type":37,"name":38,"description":39,"armGroupLabels":40},"PROCEDURE","Isotonic solution","Isotonic solution irrigation delivered through the CleaRRAflow catheter into the ventricular system to promote intraventricular hemorrhage clearance.",[41],"Isotonic solution irrigation",[43,47],{"measure":44,"description":45,"timeFrame":46},"Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion on the Speed of Intraventricular Hemorrhage (IVH) Clearance","Assess through measurement of blood volume seen on imaging in the form of daily Head CT or Head MRI","Enrollment through 90 days",{"measure":48,"description":49,"timeFrame":46},"Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion on Ventricular Catheter Liberalization","Record duration of time catheter is in place. Timepoints will be recorded from the medical record.",[51,55,58,61,65,68,71,74,77,80],{"measure":52,"description":53,"timeFrame":54},"Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion on the Inflammatory Proteomic Profile in Cerebrospinal Fluid (CSF) in Patients with Irrigating Ventricular Catheters","Using Meso scale discovery (MSD) platform with inflammatory marker panels, the proteomic profile of CSF will be evaluated.","Baseline through 10 days",{"measure":56,"description":57,"timeFrame":54},"Assess the Presence of Tissue Plasminogen Activator (TPA) within the Cerebrospinal Fluid (CSF) Following Administration","ELISA assay will be utilized to determine if TPA is present in CSF samples.",{"measure":59,"description":60,"timeFrame":54},"Assess the Breakdown of Tissue Plasminogen Activator (TPA) within the Cerebrospinal Fluid (CSF) Following Administration","ELISA assay will be utilized to determine the concentration of TPA present in CSF samples.",{"measure":62,"description":63,"timeFrame":64},"Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Shunt Dependency","Absence or Placement of shunt will be recorded from the clinical\u002Fmedical record.","Baseline through 90 days",{"measure":66,"description":67,"timeFrame":64},"Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Functional Outcomes","Modified Rankin Score at Baseline, Discharge, and 90 day time points.",{"measure":69,"description":70,"timeFrame":64},"Assess the impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Mortality","Medical records will be reviewed and mortality will be documented at discharge and 90 days.",{"measure":72,"description":73,"timeFrame":64},"Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Ventilator Days","Medical records will be reviewed and number of days on ventilator will be documented.",{"measure":75,"description":76,"timeFrame":64},"Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on ICU Length of Stay","Medical records will be reviewed and number of days in the ICU will be documented.",{"measure":78,"description":79,"timeFrame":64},"Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Hospital Length of Stay","Medical records will be reviewed and number of days in the hospital will be documented.",{"measure":81,"description":82,"timeFrame":64},"Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Hospitalization Costs","Hospitalization costs will be assessed by combining above outcome measures (ICU length of stay, time on ventilator, overall length of stay)","ALL","18 Years","99 Years",{"inclusion":87,"exclusion":92,"raw_text":97},[88,89,90,91],"Male or female, age 18 years and older","Intraventricular hemorrhage requiring EVD placement for treatment as determined by the cerebrovascular neurosurgical faculty member caring for the patient as per standard of care","Baseline mRS 0 or 1","Consenting requirements met as outlined below",[93,94,95,96],"IVH of traumatic origin","Inability to initiate treatment within 24 hours of presentation","Incarcerated individuals, pregnant individuals, or other conditions as deemed by the investigator to potentially confound study data","Presence of evidence of severe brainstem dysfunction on presentation (absence of brain stem reflexes, fixed\u002Fdilated pupils)","Inclusion Criteria:\n\n* Male or female, age 18 years and older\n* Intraventricular hemorrhage requiring EVD placement for treatment as determined by the cerebrovascular neurosurgical faculty member caring for the patient as per standard of care\n* Baseline mRS 0 or 1\n* Consenting requirements met as outlined below\n\nExclusion Criteria:\n\n* IVH of traumatic origin\n* Inability to initiate treatment within 24 hours of presentation\n* Incarcerated individuals, pregnant individuals, or other conditions as deemed by the investigator to potentially confound study data\n* Presence of evidence of severe brainstem dysfunction on presentation (absence of brain stem reflexes, fixed\u002Fdilated pupils)",[99,100],"ADULT","OLDER_ADULT",[102],{"facility":103,"city":104,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":114},"UKHC","Lexington","Kentucky","40536-0298","United States",[109],{"name":110,"role":111,"phone":112,"email":113},"Jennifer Isaacs","CONTACT","8593234738","jennifer.isaacs@uky.edu",{"lat":115,"lon":116},37.98869,-84.47772,[118],{"name":119,"role":111,"phone":120,"email":113},"Jennifer R Isaacs, MS, MS","859-323-4738",[],[],[],{"nct_id":4,"conditions":125,"biomarkers":126},[20],[],{"nct_id":4,"found":15,"summary":128,"prompt_version":128},null]