Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT07239375

Intraosseous Infusion in Hematologic Critical Patients

Led by Shanxi Bethune Hospital · Updated on 2025-11-20

52

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Intraosseous Infusion in Hematologic Critical Patients

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years old
  • Critically ill patients with hematologic diseases including rapidly progressing lethal hematological diseases
  • Patients with hematological disorders complicated by severe conditions such as agranulocytosis, thrombocytopenia, severe anemia, advanced tumors, septic shock, sepsis, disseminated intravascular coagulation, severe gastrointestinal bleeding, central nervous system involvement, or intracranial hemorrhage
  • Patients with hematological diseases combined with organ dysfunction including respiratory, heart, kidney, or liver failure
  • Patients undergoing hematopoietic stem cell transplantation or with serious complications from new immunotherapies such as hyperacute graft-versus-host disease, grade 3-4 cytokine release syndrome, immune effector cell associated neurotoxicity syndrome, or grade 3-4 immune checkpoint inhibitor associated interstitial lung disease
  • Other critically ill patients requiring life support and 24-hour monitoring
Not Eligible

You will not qualify if you...

  • Fracture at the intended puncture site
  • Extensive soft tissue injury at the intended puncture site causing insufficient landmarks for safe puncture
  • Local infection in the intended puncture area
  • History of major orthopedic surgery in the intended puncture region
  • Presence of a local prosthetic implant
  • Use of the intended puncture site for intraosseous access within the last 24 hours

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanxi Bethune Hospital

Taiyuan, Shanxi, China, 030000

Actively Recruiting

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Research Team

T

Tao Wang, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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