to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients with Severe Sepsis and Multiple Organ Dysfunctio
- Conditions
- Several SepsisMedDRA version: 14.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2006-002112-99-ES
- Lead Sponsor
- illy S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 488
[1] Adult patients (?18 years old) with severe sepsis and multiple organ
dysfunction.
Patients with severe sepsis are defined by the following criteria. Both criteria must be
met for a diagnosis of severe sepsis with multiple organ dysfunction.
? Presence of a suspected or proven infection. Patients with a suspected
infection must have evidence of an infection, such as white blood cells in a
normally sterile body fluid, perforated viscus, chest x-ray consistent with
pneumonia and associated with purulent sputum production, or a clinical
syndrome associated with a high probability of infection, for example,
purpura fulminans or ascending cholangitis.
? Presence of multiple organ dysfunction, which is defined as two or more
sepsis-associated organ dysfunctions defined below.
Note: A patient must have organ dysfunctions attributable to the sepsis
episode. The organ dysfunctions must be newly developed and not
explained by underlying disease processes or by the effects of concomitant
therapy. A non-sepsis-induced organ dysfunction may not be used to
qualify the patient for the study even if the organ dysfunction worsens as a
result of the sepsis episode.
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 244
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 244
2] Have documented multiple organ dysfunction for greater than 24 hours
prior to the start of study drug or the first documented sepsis-induced
organ dysfunction occurred greater than 36 hours prior to the start of
study drug.
[3] Weigh less than 30 kg or greater than 135 kg.
[4] Have a platelet count <30,000/mm3.
[5] Patients with active internal bleeding or at increased risk for bleeding,
for example:
(a) Any major surgery, defined as surgery that requires general or
spinal anesthesia, performed within the 12-hour period
immediately preceding the drotrecogin alfa (activated) infusion,
or any postoperative patient who demonstrates evidence of active
bleeding, or any patient with planned or anticipated surgery
during the infusion period
(b) Biopsy or surgical procedure of a closed-space within the
12 hours immediately preceding the drotrecogin alfa (activated)
infusion where there is a high risk of significant bleeding and
where it would not be possible to control bleeding by external
pressure.
(c) History (within the previous 3 months) of stroke or severe head
trauma that required hospitalization or intracranial surgery.
(d) History of intracranial arteriovenous malformation, cerebral
aneurysm, or central nervous system mass lesion.
(e) Patients with an epidural catheter or who are anticipated to
receive an epidural catheter during drotrecogin alfa (activated)
infusion.
(f) History of congenital bleeding diatheses (for example,
hemophilia).
(g) Gastrointestinal bleeding within the 6 weeks prior to study entry
that required medical intervention unless definitive endoscopic
procedure or surgery has been performed.
(h) Trauma patients at increased risk of bleeding (for example, flail
chest; significant contusion to lung, liver, or spleen;
retroperitoneal bleed; pelvic fracture; compartment syndrome).
(i) Patients with known esophageal varices, chronic jaundice,
cirrhosis, or chronic ascites.
[6] Have a concurrent need for any of the following medications during
the drotrecogin alfa (activated) infusion:
(a) Therapeutic heparin, defined as unfractionated heparin
>15,000 units/day within 8 hours of study entry or low molecular
weight heparin used at any dose higher or more frequent than the
recommended dose in the product label for prophylaxis within
12 hours of study entry.
(b) Warfarin, if used within 7 days of study entry or warfarin-type
medications within <5 half-lives at the time of study entry and
where the prothrombin time (PT) is prolonged beyond the upper
limit of normal for the institution.
(c) Antiplatelets such as ticlopidine, clopidogrel, or acetylsalicylic
acid (ASA) >650 mg/day or compounds that contain ASA
>650 mg/day within 3 days prior to study entry.
(d) Thrombolytic therapy (unless used to treat an intra-catheter
thrombosis; however, care should be taken to avoid systemic
administration) if used within 3 days of study enrollment (for
example, streptokinase, tPA, rPA, and urokinase).
(e) Glycoprotein IIb/IIIa receptor antagonists within 7 days of study
entry.
(f) Antithrombin infusion of >10,000 units within 12 hours of study
entry.
(g) Protein C concentrate infusion within 24 hours of study entry.
(h) Other anticoagulants, such as direct thrombin inhibitors
and factor Xa inhibitors and other synthetic heparinoids within
<5 half-lives of study entry.
(i) Recombinant factor VIIa within the past 30 days.
[7] Are not expected to survive 28 days given their preexisting
uncorrectable medical condition. (See Protocol Attac
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method