linastatin in patient with Trauma to prevent progression to multiple organ dysfunctio
Phase 4
Completed
- Conditions
- Health Condition 1: null- multiple organ dysfunction syndromeHealth Condition 2: R651- Systemic inflammatory response syndrome (SIRS) of non-infectious origin
- Registration Number
- CTRI/2012/11/003144
- Lead Sponsor
- Bharat Serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
I. Age >18yrs <65yrs (both inclusive)
II. Patients with potentially life threatening injury (ISS >= 9 and RTS >= 6)
III. Drug administration should commence within 24 hours of injury
IV. Evidence of SIRS and/or sepsis
Exclusion Criteria
Pregnant or breast-feeding.
2. Age < 18yrs or >65yrs.
3. Very severe injury wherein patient is unlikely to survive till the end of Investigational Product.
4. Patients with severe head injury (Glasgow Coma Scale <= 8)
5. Known case of major co-morbid (medical) illnesses.
6. Known case of chronic cardiac, kidney, lung or liver disease.
7. Known case of immunocompromised / Immunosuppressed status.
8. Participation in another investigational study within 30 days before thecurrent study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method