Intraosseous Infusion in Hematologic Critical Patients

NCT07239375 | Recruiting

• 1 other identifier: ShanxiBethuneH4
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• First-Attempt Intraosseous Access Success Rate at 24 Hours

  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.

  Assessed immediately upon IO needle placement (for success criteria) and continuously monitored for functionality for 24 hours post-placement.

• The treatment efficacy

  The treatment efficacy includes the recovery effect of blood routine indicators and the treatment effect of primary diseases,and overall survival rate.

  Assessed immediately upon IO needle placement (for success criteria) and continuously monitored for functionality for 24 hours post-placement.

Secondary Outcomes (4)

• Overall Complication Rate Related to Intraosseous Infusion

  From the time of IO access placement up to 7 days after removal, with specific assessments at 24 hours, 72 hours, and 1 month post-placement.

• Time to Achieve Hemodynamic Stability

  Assessed continuously from IO access establishment until the point of hemodynamic stability is first met, up to 6 hours post-procedure.

• Infusion Success Rate at Target Flow Rate

  Assessed during a standardized test infusion performed within 15 minutes after successful IO placement.

• 30-day All-Cause Mortality

  From the date of IO access placement up to 30 days.

Interventions

intra-osseous (IO) infusion needle/catheter DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Population: Fifty-two adult patients (18-65 years) with critical hematologic disorders and poor vascular access will be enrolled. All are at imminent risk of death and include: ① rapidly progressive, highly lethal hematologic malignancies; ② severe complications such as agranulocytosis, major bleeding, DIC, CNS involvement, or sepsis; ③ concomitant respiratory, cardiac, renal, or hepatic failure; ④ life-threatening toxicities from HSCT or novel immunotherapies (hyperacute GVHD, grade 3-4 CRS/ICANS, grade 3-4 ICI-related pneumonitis); ⑤ any other critically ill patient requiring 24-h organ-supportive care.

You may qualify if:

• \. 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:

• \. 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).

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

MeSH Terms

Interventions

Catheters

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Tao Wang, Dr.

CONTACT

13835175119; wangtao99699@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 22, 2025
• Primary Completion (Estimated): October 22, 2027
• Study Completion (Estimated): October 23, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

CN (1)