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Efficacy and Safety of Prothrombin Complex Concentrate for Progressive Hemorrhagic Injury after Traumatic Brain Injury

Prothrombin complex concentrate for intraparenchymal contusion and hemorrhage progression in patients with traumatic brain injury:a randomized,double-blind trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035784
Enrollment
Unknown
Registered
2020-08-16
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Traumatic Brain Injury

Interventions

prothrombin complex group:20IU of prothrombin complex per kilogram
placebo group:same volume of placebo

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients agreed to participate and signed informed consent forms; 2. Adult patients (range from 18 to 76 years old) with closed traumatic brain injury, who were admitted in 48 hours; 3. Patients with intraparenchymal contusion and hemorrhage.

Exclusion criteria

Exclusion criteria: 1. Patients with open craniocerebral injury; 2. Patients with severe multiple organ injury (Abbreviated Injury Score > 3); 3. Patients underwent operation on the first head CT; 4. Patients with intracranial pathological changes before their injury; 5. Patients with isolate traumatic epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, brain stem contusion, cerebellar contusion/ hemorrhage; 6. Patients with known organ disorders, such as coronary heart disease, renal failure, liver dysfunction and so on. 7. Patients taking anticoagulant therapies that could result in coagulopathies; 8. Patients with disease associated with thrombosis such as cerebra infarction, myocardiac infarction before TBI.

Design outcomes

Primary

MeasureTime frame
the percent change in the volume of the intraparenchymal contusion and hemorrhage;

Secondary

MeasureTime frame
Growth in the volume of intraparenchymal contusion and hemorrhage;rate of Progressive Hemorrhagic Injury;GOSE;

Countries

China

Contacts

Public ContactFang Yuan

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

yf021025@126.com+86 18930174964

Outcome results

None listed

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