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Clinical application research of hyperosmotic albumin in patients with moderate to severe traumatic brain injury

Clinical application research of hyperosmotic albumin in patients with moderate to severe traumatic brain injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096550
Enrollment
Unknown
Registered
2025-01-26
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Moderate-severe head injury

Interventions

Experimental group:A 25% human blood albumin transfusion is given in addition to conventional hyperosmolar therapy to maintain albumin levels above 35 g/dL
Control group:Follow a protocol for dehydration and intracranial pressure reduction based on hypertonic drugs such as mannitol

Sponsors

Changxing County Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18 years; 2. The patient has a craniocerebral injury, and there is a basis for imaging to support the diagnosis; 3. GCS score of 12 and below; 4. Not participating in other clinical intervention trials; 5. The patient or his/her legal representative has informed consent and voluntarily participates in the study.

Exclusion criteria

Exclusion criteria: 1. Previous liver diseases such as liver cirrhosis; 2. Death within 48 hours of admission to the ICU; 3. Concomitant severe mental illness; 4. Pregnancy; Age>=75 years; Cardiac insufficiency, cardiac function grade III-IV; 5. For some reasons, the patient refuses to undergo relevant examinations or is unable to obtain relevant complete information; 6. Those who need to discontinue the study due to force majeure factors such as change in condition, death or transfer to hospital.

Design outcomes

Primary

MeasureTime frame
28-day death rate;

Secondary

MeasureTime frame
Length of ICU stay;Duration of mechanical ventilation;Hospitalization costs;Acute Physiology and Chronic Health Evaluation II;Glasgow Coma Scale, GCS;

Countries

China

Contacts

Public ContactZhang Yougui

Changxing County Hospital of Traditional Chinese Medicine

qizhi02@163.com+86 572 6041300

Outcome results

None listed

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