Integrilin and Ilomedin in Combination in Comparison to Standard Treatment in Severe Pneumonia Patients With Severe Sepsis
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|ClinicalTrials.gov Identifier: NCT01532544|
Recruitment Status : Terminated (Difficulty recruiting patients, company closed down)
First Posted : February 14, 2012
Last Update Posted : April 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Drug: Ilomedin and Integrilin Drug: low molecular weight heparin.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-blinded, Randomized Trial in Severe Pneumonia Patients With Severe Sepsis Investigating the Safety and Efficacy of Co-administration of Iloprost and Ascending Doses of Eptifibatide Compared to Low-molecular-weight Heparin|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
|Experimental: Integrilin and Ilomedin given as continous infusion||
Drug: Ilomedin and Integrilin
Other Name: Integrilin and Ilomedin
Placebo Comparator: Standard treatment daily doses of low molecular weight heparin
Standard treatment daily doses of low molecular weight heparin.
Drug: low molecular weight heparin.
- Change in platelet count from baseline to 72 hours post treatment [ Time Frame: 11 bloodsamples over 7 days ]Will be from pre-study drug administration until 7 days
- Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more) (KyperSept trial) [ Time Frame: 7 days ]If longer in the ICU ward followed until discharged.
- Days of vasopressor, ventilator and renal replacement therapy and use of blood product (in ICU) after randomization [ Time Frame: 7 days ]Followed longer if not discharged from the ICU at day 7
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532544
|University hospital Copenhagen|
|Copenhagen, Denmark, 2100|
|Kuopio University Hospital|
|Tampere University Hospital|
|Tampere, Finland, 33521|