Efficacy of Lyophilized Human Prothrombin Complex Concentrate on acute patients with hemorrhage: a single arm phase II study

Efficacy of Lyophilized Human Prothrombin Complex Concentrate on acute patients with hemorrhage: a single arm phase II study - Lyophilized Human Prothrombin Complex Concentrate on acute patients: a single arm phase II study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030812

Enrollment

Registered

2018-01-15

Start date

2018-01-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Severe trauma patients with cerebral hemorrhage, those who were admitted to the Advanced Critical Care and Emergency Center and had less than 2 in PT-INR

Interventions

1) Once during a hospital stay 2) Amount PT-INR &gt

=2, &lt

4: body weight&lt

=100kg = 25IU/kg, body weight&gt

100kg = 2500IU PT-INR &gt

=4, &lt

=6: body weight&lt

=100kg = 35IU/kg, body weight&gt

100kg = 3500IU PT-INR &gt

6: body weight&lt

=100kg = 50IU/kg, body weight&gt

100kg = 5000IU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Severe trauma patients with cerebral hemorrhage, those who were admitted to the Advanced Critical Care and Emergency Center and had less than 2 in PT-INR

Exclusion criteria

Exclusion criteria: 1) Severe trauma patients with cerebral hemorrhage, those who were admitted to the Advanced Critical Care and Emergency Center and had greater than or equal to 2 in PT-INR 2) Patients, those who were determined by a physician as not-adequate to include the study

Design outcomes

Primary

Measure	Time frame
Changes in hemorrhage between the beginning of medication and hospital discharge	—

Countries

Japan

Contacts

Public ContactTakashi Kawasaki

Yokohama City University Medical Center Advanced Critical Care and Emergency Center

tks59jn@gmail.com045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026