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Intraosseous Infusion in Hematologic Critical Patients

NCT07239375 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2025-11-20

No results posted yet for this 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.

Conditions

  • Intraosseous Infusions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Shanxi Bethune Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-22
Primary Completion
2027-10-22
Completion
2027-10-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07239375 on ClinicalTrials.gov