Intraosseous infusion for critically ill hematology patients

Application of Intraosseous Infusion in Hematologic Critical Patients

This study will test whether intraosseous (through-the-bone) needle infusions provide fast, reliable vascular access for adults 18–65 with severe hematologic conditions in the intensive care setting.

Quick facts

• Study type: Observational
• Enrollment: 52 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanxi Bethune Hospital (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT07239375 on ClinicalTrials.gov

What this trial studies

This is a single-center, prospective observational study that will enroll 52 critically ill hematology patients aged 18–65. An intraosseous (IO) cannula will be placed in the proximal tibia and investigators will record time to vascular access, first-pass success, infusion flow rates during dwell, and measures of hemodynamic recovery and volume resuscitation. The protocol will also track stability of vasoactive drug delivery and procedural complications such as local infection and fat embolism, with overall survival as an outcome. The goal is to determine whether IO infusion is a rapid, non-collapsible alternative for vascular access in the hematologic intensive care population.

Who should consider this trial

Good fit: Adults 18–65 with severe or rapidly progressing hematologic diseases or complications (for example agranulocytosis, thrombocytopenia, severe anemia, septic shock, DIC, major bleeding, organ failure, or post-transplant/immune therapy complications) who require urgent vascular access in the hematologic ICU are ideal candidates.

Not a fit: Patients outside the 18–65 age range, those with local contraindications to tibial IO insertion (such as fracture or severe bone disease at the site), or stable patients who already have functioning central or peripheral access are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, IO infusion could offer a faster, more reliable way to deliver fluids and lifesaving medications when conventional vascular access is difficult in critically ill hematology patients.

How similar studies have performed: Intraosseous access is well established in emergency and pediatric resuscitation with demonstrated rapid access and effective drug delivery, but its targeted use and outcomes in critically ill hematology patients remain relatively novel and less well studied.

Eligibility criteria

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).

Where this trial is running

Taiyuan, Shanxi

• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Tao Wang, Dr.

Conditions Intraosseous Infusions