Skip to content

The efficacy and safety of intraosseous infusion in the treatment of severe traumatic hemorrhagic shock: A single-center, randomized, parallel-controlled clinical trial

The efficacy and safety of intraosseous infusion in the treatment of severe traumatic hemorrhagic shock: A single-center, randomized, parallel-controlled clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091079
Enrollment
Unknown
Registered
2024-10-21
Start date
2024-10-21
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

traumatic hemorrhagic shock

Interventions

Intervention group:Intraosseous catheterization
Control group:Central venous catheterization

Sponsors

First Affiliated Hospital of Suzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Ages between 18 and 75 years, gender not specified; 2. Clinically diagnosed with severe traumatic hemorrhagic shock (manifested by altered consciousness, tachycardia, pale and cold skin, decreased blood pressure, etc.), and in need of urgent rescue; 3. Time from injury to presentation does not exceed 6 hours, vital signs are unstable, and meet the relevant diagnostic criteria for traumatic hemorrhagic shock according to the "Chinese Emergency Expert Consensus on the Diagnosis and Treatment of Traumatic Hemorrhagic Shock," namely: shock combined with hypotension (systolic blood pressure < 90 mmHg, pulse pressure difference < 20 mmHg, or a decrease in systolic blood pressure = 40 mmHg from baseline in those with pre-existing hypertension); 4. No other severe complications, such as serious heart disease, cerebrovascular disease, malignant tumors, etc.; 5. The patient or their family signs an informed consent form, agreeing to participate in this study and adhere to the research protocol; 6. Other conditions deemed suitable for participation in this study by the researchers.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications for catheter placement, such as lower limb deformities, tibial fractures, right-sided pneumothorax, etc.; 2. Pregnant or lactating women; 3. Patients known to be allergic to the study medication or infusion materials; 4. Patients with severe coagulation disorders who cannot undergo intraosseous infusion; 5. Patients with severe infections, sepsis, or other conditions that may lead to intraosseous infection; 6. Patients who have received other treatments or medications that may affect the results of this study prior to its commencement; 7. Other conditions deemed inappropriate for participation in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
First-time puncture success rate;

Secondary

MeasureTime frame
Number of punctures;Catheterization time;Time taken to establish the infusion access;Success rate of treatment within 4 hours;In-hospital mortality rate;

Countries

China

Contacts

Public ContactYang Peng

First Affiliated Hospital of Suzhou University

yangpeng@suda.edu.cn+86 138 0613 1182

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026