intra-osseous (IO) infusion needle/catheter: The 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 1\. Fracture at the intended puncture site (due to the risk of fluid extravasation into subcutaneous tissues).
2\. Extensive soft tissue injury at the intended puncture site, resulting in insufficient anatomical landmarks for safe puncture.
3\. Local infection in the intended puncture area. 4. History of major orthopedic surgery in the intended puncture region. 5. Presence of a local prosthetic implant. 6. A site previously used for intraosseous (IO) access within the last 24 hours (to avoid re-puncture).
Primary outcome measure(s)
First-Attempt Intraosseous Access Success Rate at 24 Hours — Assessed immediately upon IO needle placement (for success criteria) and continuously monitored for functionality for 24 hours post-placement. 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.
The treatment efficacy — Assessed immediately upon IO needle placement (for success criteria) and continuously monitored for functionality for 24 hours post-placement. The treatment efficacy includes the recovery effect of blood routine indicators and the treatment effect of primary diseases,and overall survival rate.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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