Intraosseous Infusion in Hematologic Critical Patients
ConditionIntraosseous Infusions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorShanxi Bethune Hospital
About this trial
This single-center, prospective observational study will enroll 52 critically hematology patients aged 18-65 years including agranulocytosis, thrombocytopenia, severe anemia, advanced tumors, septic shock, sepsis DIC、 severe gastrointestinal bleeding, involvement of the central nervous system or intracranial hemorrhage, patients undergoing hematopoietic stem cell transplantation，etc. Vascular access will be established via intraosseous (IO) needle placement, primarily to evaluate first-attempt puncture success rate, therapeutic efficacy, and overall survival rate. Secondary endpoints include infusion speed, hemodynamic improvement, and procedural complications such as local infection and fat embolism. The study aims to definitively assess the efficacy and safety of IO infusion as a rapidly established, "non-collapsible" alternative vascular access route in the hematologic intensive care setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age: 18 to 65 years old. 2. Critically patients with hematologic diseases, including:① Highly suspected or diagnosed patients with rapidly progressing highly lethal hematological diseases;② Patients with hematological disorders complicated by severe complications, including agranulocytosis, thrombocytopenia, severe anemia, advanced tumors,septic shock, sepsis, DIC、 severe gastrointestinal bleeding, involvement of the central nervous system or intracranial hemorrhage, etc;③ Patients with hematological diseases combined with important organ dysfunction, including respiratory failure, heart failure, renal failure, liver failure, etc;④ Patients undergoing hematopoietic stem cell transplantation or those experiencing serious complications in new immunotherapy, such as hyperacute graft-versus-host disease (GVHD), grade 3-4 cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS), grade 3-4 immune checkpoint inhibitor associated interstitial lung disease, etc;⑤ Other critically patients who require life support and 24-hour monitoring.
Disqualifiers
1. Fracture at the intended puncture site (due to the risk of fluid extravasation into subcutaneous tissues).
Trial population
Study Population: Fifty-two adult patients (18-65 years) with critical hematologic disorders and poor vascular access will be enrolled. All are at imminent risk of death and include: ① rapidly progressive, highly lethal hematologic malignancies; ② severe complications such as agranulocytosis, major bleeding, DIC, CNS involvement, or sepsis; ③ concomitant respiratory, cardiac, renal, or hepatic failure; ④ life-threatening toxicities from HSCT or novel immunotherapies (hyperacute GVHD, grade 3-4 CRS/ICANS, grade 3-4 ICI-related pneumonitis); ⑤ any other critically ill patient requiring 24-h organ-supportive care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
intra-osseous (IO) infusion needle/catheter
DeviceThe interventional approach employed in this study is intraosseous (IO) infusion. This technique involves the percutaneous insertion of a specialized intraosseous needle or a powered driver device into the medullary cavity of a long bone (e.g., proximal tibia or humerus) to establish rapid vascular access for the administration of fluids, medications, and blood products. Its core principle leverages the bone marrow space as a "non-collapsible venous sinus," providing a rapid and effective life-saving channel for critically ill hematology patients-such as those with concomitant shock, severe hemorrhage, or multiple organ dysfunction-in whom conventional vascular access is challenging due to critical illness or underlying coagulopathies.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
First-Attempt Intraosseous Access Success Rate at 24 Hours
First-Attempt Intraosseous Access Success Rate at 24 Hours Defined as the proportion of patients in whom a functional intraosseous (IO) access is successfully established on the first needle insertion attempt, and which remains functional for 24 hours. Success is confirmed by: 1) Aspiration of bone marrow contents, AND 2) Free flow of saline flush without subcutaneous infiltration, AND 3) Ability to administer fluids/drugs at the desired rate.
Time frame
Assessed immediately upon IO needle placement (for success criteria) and continuously monitored for functionality for 24 hours post-placement.2
The treatment efficacy
The treatment efficacy includes the recovery effect of blood routine indicators and the treatment effect of primary diseases,and overall survival rate.
Time frame
Assessed immediately upon IO needle placement (for success criteria) and continuously monitored for functionality for 24 hours post-placement.Secondary outcomes
1
Overall Complication Rate Related to Intraosseous Infusion
Overall Complication Rate Related to Intraosseous Infusion The proportion of patients experiencing any complication attributable to the IO procedure. Complications include, but are not limited to: local pain requiring analgesia beyond the protocol-specified lidocaine, significant swelling, hematoma, subcutaneous infiltration of fluid, infection at the puncture site (assessed by redness, warmth, purulent discharge, or positive culture), osteomyelitis, compartment syndrome, limb fracture, fat embolism, or nerve injury.
Time frame
From the time of IO access placement up to 7 days after removal, with specific assessments at 24 hours, 72 hours, and 1 month post-placement.2
Time to Achieve Hemodynamic Stability
Time to Achieve Hemodynamic Stability ：The time interval measured from the successful establishment of IO access to the achievement of pre-defined hemodynamic stability. Stability is defined as: mean arterial pressure (MAP) ≥ 65 mmHg without increased vasopressor support, and/or heart rate (HR) decreasing to \< 120 beats per minute and maintained for at least 30 minutes.
Time frame
Assessed continuously from IO access establishment until the point of hemodynamic stability is first met, up to 6 hours post-procedure.3
Infusion Success Rate at Target Flow Rate
The proportion of established IO accesses that are capable of delivering intravenous fluids or blood products at a clinically acceptable target flow rate (e.g., ≥ 100 mL/min for tibial site or ≥ 150 mL/min for humeral site) without failure (e.g., dislodgement, occlusion, or significant leakage).
Time frame
Assessed during a standardized test infusion performed within 15 minutes after successful IO placement.4
30-day All-Cause Mortality
The proportion of patients who die from any cause within 30 days following the establishment of intraosseous access.
Time frame
From the date of IO access placement up to 30 days.Sponsors and contacts
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Source ClinicalTrials.gov