Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
2 May 2016 |
Main ID: |
NCT01532544 |
Date of registration:
|
30/01/2012 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Integrilin and Ilomedin in Combination in Comparison to Standard Treatment in Severe Pneumonia Patients With Severe Sepsis
|
Scientific 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 |
Date of first enrolment:
|
June 2012 |
Target sample size:
|
5 |
Recruitment status: |
Terminated |
URL:
|
https://clinicaltrials.gov/show/NCT01532544 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
Phase:
|
Phase 2
|
|
Countries of recruitment
|
Denmark
|
Finland
| | | | | | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. At least 18 years of age AND
2. Suspected or proven bacterial pneumonia requiring administration of antibiotics:
- Clinical diagnosis of pneumonia, (i.e. new or increased cough, production of
purulent sputum or a change in the character of sputum in subjects who normally
have purulent sputum, typical auscultatory findings of pneumonia on chest
examination) and:
- chest radiograph or CT within the last 24 hr showing a pulmonary infiltrate.
3. Dyspnea and/or tachypnea (>20 breaths/minute) or mechanical ventilation
4. Two or more systemic inflammatory response syndrome (SIRS) criteria within the last
24 hours:
- Temperature = 36° C or >/= 38°C
- Heart rate >/= 90 beats per minute
- Mechanical ventilation for acute respiratory process or respiratory rate >/= 20
breaths per minute or PaC02 < 4.2 kPa
- WBC >/= 12,000/mm³ OR = 4,000/mm³ OR > 10% bands
5. At least one organ failure beyond respiratory failure (cerebral, cardiovascular,
hepatic, renal or coagulation within the last 24 hours (> 2 in SOFA score for the
specific organ system) AND
6. Can be randomized into trial and dosed < 48 h after severe sepsis diagnosis AND
7. Consent is obtainable -
Exclusion Criteria:
1. Patient is pregnant or breast-feeding
2. Patient weigh more than 125 kg
3. Patients with known allergy towards any of the investigational products or
contraindications which should be excluded according to the investigational product
specifications
4. Investigators clinical decision deeming study participation not favourable for the
patient
5. Patients in whom the clinician finds antithrombotic therapy contraindicated -
prophylaxis included
6. Patients at increased risk of bleeding: Surgery in the previous 12 h, expected
surgery within 72 h, epidural or spinal puncture in the previous 12 h, platelet count
less than 30,000/mm3 in the previous 24 h, INR above 2.0 in the previous 24 h, need
of blood products for bleeding in the previous 24 h, treatment with any
antithrombotics within 12 h (profylaxis excepted), current or previous intracranial
bleeding or traumatic brain or spinal injury within the last month.
7. Patients requiring any form of antithrombotics (beyond profylaxis) in therapeutic
doses or prothrombotics in any dose, including,
- unfractionated heparin within 8 hours before the infusion (prophylactic heparin
up to 15,000 U/day permitted).
- Low-molecular-weight heparin within 12 hours (prophylactic doses permitted).
- exceeded the upper limit of normal.
- Acetylsalicylic acid more than 650 mg/day within 3 days before the study.
- Thrombolytic therapy within 3 days before the study (catheter clearance doses
permitted).
- Glycoprotein IIb-IIIa antagonists within 7 days before the study.
- Antithrombin III with dose greater than 10,000 U within 12 hours before the
study.
- Protein C within 24 hours of the study.
8. Previous diagnosed condition that might mimic or complicate the course and evaluation
of the infectious disease process (severe bronchiectasis, lung abcess or empyema,
aspiration pneumonia, active tuberculosis, pulmonary malignancy, cystic fibrosis,
severe chronic interstitial pneumonia, COPD or other forms of chronic lung disease
requiring home oxygen treatment or resulting in chronic CO2 retention, , etc.)
9. Patient not expected to survive more than 30 days because of uncorrectable medical or
surgical condition other than sepsis
10. Patient with acute or chronic renal failure requiring dialysis (renal failure without
need for dialysis permitted).
11. Patient with hematological malignancies of any kind
12. Patients who have undergone transplantation of bone marrow, liver, pancreas, heart,
lung, or bowel (kidney transplant permitted)
13. Patient has known hypercoagulable condition:
APC resistance Hereditary protein C, protein S, or antithrombin III deficiency
Anticardiolipin or antiphospholipid antibody Lupus anticoagulant Homocysteinemia
Recent or highly suspected pulmonary embolism or deep venous thrombosis (within 3
months)
14. Patients with known congenital hypocoagulable diseases
15. Patient with known AIDS
16. Patient with known primary pulmonary hypertension
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Pneumonia
|
Intervention(s)
|
Drug: low molecular weight heparin.
|
Drug: Ilomedin and Integrilin
|
Primary Outcome(s)
|
Change in platelet count from baseline to 72 hours post treatment
[Time Frame: 11 bloodsamples over 7 days]
|
Secondary Outcome(s)
|
Days of vasopressor, ventilator and renal replacement therapy and use of blood product (in ICU) after randomization
[Time Frame: 7 days]
|
Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more) (KyperSept trial)
[Time Frame: 7 days]
|
Secondary ID(s)
|
2011-002254-31
|
THR-PS-03
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|