Cinryze for the acute management of severe traumatic brain injury

Phase 1

• Conditions: Severe traumatic Brain Injury (TBI) with GCS < 13; MedDRA version: 20.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2020-000140-58-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-25
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Age at admission = 18 years and < 65 years;
-Clinical diagnosis of traumatic brain injury with GCS < 13 (with intra cranial deviations);
-Catheter placement for monitoring and management of increased ICP for at least 24 hours;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 106
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- A clear, non-traumatic cause of low GCS (e.g. toxic, cardial) on admission;
- Not expected to survive more than 24 hours after admission;
- Brain death on arrival in the participating centres;
- Severe pre-trauma disability, defined as being dependent on other people;
-Known prior history of sensibility to blood products or Cinryze;
- Patients with a history of hereditary angioedema;
-Patients with a history of thrombosis
- Pregnant women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified