Efficacy and safety of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions: prospective single arm clinical trial

Efficacy and safety of early fibrinogen concentrate substitution therapy for severe trauma patients receiving massive transfusions: prospective single arm clinical trial - Pilot study of early fibrinogen concentrate substitution therapy for severe trauma patients

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010294

Enrollment

Registered

2013-04-01

Start date

2013-05-17

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

Interventions

freeze-dried human fibrinogen Fibrinogen HT i.v. 1g - BENESIS only the receiving injury day dosage 2g or 3g/time maximum of two times Hemorrhagic trauma patients, whose serum fibrinogen concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: arrive at hospital within 3 hours after accident shock or pre-shock serum fibrinogen <=150mg/dl

Exclusion criteria

Exclusion criteria: (1)history of venous thromboembolism (2)thrombotic diathesis (such as antithrombin deficiency,Protein S/C deficiency,antiphospholipid antibody syndrome) (3)Agreement acquisition is impossible from the patient and the family.

Design outcomes

Primary

Measure	Time frame
the amount of blood transfusion for 24 hours after the hospital arriving mortality for 72 hours after the hospital arriving morbidity of venous thromboembolism during the hospital stay	—

Countries

Japan

Contacts

Public ContactKoichi Inokuchi

Saitama Medical Center, Saitama Medical University Department of Emergency and Critical Care Medicine

inok_k@saitama-med.ac.jp0492283597

Outcome results

None listed

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