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A randomized controlled trial for Lund concept in the treatment of severe craniocerebral injury

A randomized controlled trial for Lund concept in the treatment of severe craniocerebral injury

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026592
Enrollment
Unknown
Registered
2019-10-15
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

severe traumatic brain injury

Interventions

Experimental group:1. Maintain hemoglobin and plasma albumin infusion of less white erythrocytes or red blood cells, maintain hemoglobin 125 ~ 140g / L, infusion 20 ~ 25% albumin to maintain albumin 3
2. Reduce intracranial pressure Mainly by reducing cerebral perfusion pressure (CPP).
Control group:Dehydration and intracranial pressure reduction program based on hypertonic drugs such as mannitol

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. STBI patients: Glasgow coma score (GLS) 6 hours, or consciousness worsened and coma > 6 hours within 24 hours after injury; 2. aged 18 to 70 years old; 3. Patients who have intracranial pressure monitoring within 48 hours of onset.

Exclusion criteria

Exclusion criteria: 1. The cerebral perfusion pressure is less than 10mmHg after the patient arrives at the hospital; 2. GCS 3 points after the patient arrives at the hospital, the pupil is dilated and fixed; 3. Pregnancy or breastfeeding; 4. The estimated survival time of malignant tumors is less than 2 months; 5. Inability to obtain informed consent or authorization; 6. Participate in other exploratory clinical trials within 6 months prior to screening; 7. Cardiopulmonary resuscitation received within 72 hours prior to enrollment.

Design outcomes

Primary

MeasureTime frame
28-day mortality rate;

Secondary

MeasureTime frame
Hospital stay, ICU time, hospitalization cost, mechanical ventilation time, APACHE II score, GCS score, mannitol dose, 60-day mortality, 28-day and 60-day GOS score (Glasgow Outcome Scale Glasgow Outcome Score);

Countries

China

Contacts

Public ContactTongwen Sun

The First Affiliated Hospital of Zhengzhou University

suntongwen@163.com+86 13838516916

Outcome results

None listed

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