Intraosseous Infusion in Hematologic Critical Patients

Recruiting now

Conditions studied: Intraosseous Infusions

In brief

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.

Key facts

Study ID

NCT07239375

Run by

Shanxi Bethune Hospital

People needed

52

Starts

2025-11-22

Expected to finish

2027-10-23

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 1. Fracture at the intended puncture site (due to the risk of fluid extravasation into subcutaneous tissues).
• Extensive soft tissue injury at the intended puncture site, resulting in insufficient anatomical landmarks for safe puncture.
• 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 it is running

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

Full record on ClinicalTrials.gov

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