Intraosseous Infusion in Hematologic Critical Patients

Application of Intraosseous Infusion in Hematologic Critical Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Intraosseous Infusions
• Intervention / Treatment: Device: intra-osseous (IO) infusion needle/catheter

Detailed Description

This single-center, prospective observational study is designed to evaluate the clinical utility of intra-osseous (IO) infusion incritically hematology patients ，including:① Highly suspected or diagnosed patients with rapidly progressing highly lethal hematological diseases;② Patients with hematological disorders complicated by severe complications, including granulocyte deficiency, thrombocytopenia, severe anemia, advanced tumors, septic shock, sepsis, etc 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.

An IO cannula will be inserted into the proximal tibia, and the following parameters will be prospectively recorded: time to vascular access, first-pass success rate, infusion flow during dwell, hemodynamic recovery, efficiency of volume resuscitation, stability of vaso-active drug delivery, and the incidence of procedure-related adverse events (local infection, fat embolism, osteomyelitis, bleeding, nerve injury). The study will explore whether IO access can serve as a reliable, rapidly established "non-collapsible" vascular route.The catheter will be removed within 24 h (maximum 96 h in exceptional cases); lidocaine step-wise analgesia will be administered according to consensus recommendations. Follow-up data will be captured in real time through an electronic case-report form (eCRF); inflammatory markers, coagulation profile, and organ-function indices will be measured by the central laboratory, while imaging specialists will assist in complication screening. The trial is intended to generate the first evidence base for IO infusion in Chinese hematology critical care and to provide feasibility and effect-size data for subsequent multicentre randomized controlled trials.

• Study Type: Observational
• Enrollment (Estimated): 52

Contacts and Locations

• Study Contact: Name: Tao Wang, Dr.; Phone Number: 13835175119; Email: wangtao99699@163.com

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Recruiting
      • Shanxi Bethune Hospital
      • Contact: Tao Wang, Dr.; Phone Number: 13835175119; Email: wangtao99699@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Complication Rate Related to Intraosseous Infusion	Overall Complication Rate Related to Intraosseous Infusion The proportion of patients experiencing any complication attributable to the IO procedure. Complications include, but are not limited to: local pain requiring analgesia beyond the protocol-specified lidocaine, significant swelling, hematoma, subcutaneous infiltration of fluid, infection at the puncture site (assessed by redness, warmth, purulent discharge, or positive culture), osteomyelitis, compartment syndrome, limb fracture, fat embolism, or nerve injury.	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	Time to Achieve Hemodynamic Stability ：The time interval measured from the successful establishment of IO access to the achievement of pre-defined hemodynamic stability. Stability is defined as: mean arterial pressure (MAP) ≥ 65 mmHg without increased vasopressor support, and/or heart rate (HR) decreasing to < 120 beats per minute and maintained for at least 30 minutes.	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	The proportion of established IO accesses that are capable of delivering intravenous fluids or blood products at a clinically acceptable target flow rate (e.g., ≥ 100 mL/min for tibial site or ≥ 150 mL/min for humeral site) without failure (e.g., dislodgement, occlusion, or significant leakage).	Assessed during a standardized test infusion performed within 15 minutes after successful IO placement.
30-day All-Cause Mortality	The proportion of patients who die from any cause within 30 days following the establishment of intraosseous access.	From the date of IO access placement up to 30 days.

Collaborators and Investigators

• Sponsor: Shanxi Bethune Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 22, 2025
• Primary Completion (Estimated): October 22, 2027
• Study Completion (Estimated): October 23, 2027

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Equipment and Supplies; Catheters
• Other Study ID Numbers: ShanxiBethuneH4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No