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A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PROFILACTIC HEPARIN IN PATIENTS WITH SEVERE SEPSIS AND HIGH-RISK MORTALITY DISEASE THAT IS UNDER TREATMENT WITH ALPHA DROTRECOGEN (ACTIVATED)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-017-04
Enrollment
Unknown
Registered
2004-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

unfractionated prophylactic heparin Type of group
The study drug will be administered by subcutaneous injection every 12 hours during the planned 96-hour infusion of Drotrecogin Alfa (Activated). Group name:placebo Type of group
The study drug will be administered by subcutaneous injection every 12 hours during the planned 96-hour infusion of Drotrecogin Alfa (Activated).

Sponsors

ELI LILLY INTERAMERICA INC.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults greater than or equal to 18 years of age Receiving inpatient treatment for severe sepsis Indicated for treatment with Drotrecogin Alfa (Activated) under approved label in the country where the patient is enrolled

Exclusion criteria

Exclusion criteria: Contraindicated for heparin treatment Require a higher dose of heparin than defined in the trial Have acute or chronic renal failure with an estimated creatinine clearance less than 30mL/min Weigh more than 135 kg (297 pounds) Are not expected to survive 28 days given their medical condition.

Design outcomes

Primary

MeasureTime frame
Outcome name:mortality. Measure:Demonstrate in adult patients with severe sepsis who are receiving drotrecogin alfa (activated) that concomitant treatment with heparin is equivalent to treatment with placebo as determined by 28-day all-cause mortality. Timepoints:28 days—

Secondary

MeasureTime frame
Outcome name:incidence of venous thrombotic events Measure:Determine the incidence of venous thrombotic events in patients receiving heparin vs. placebo through study days 6 and 28 Timepoints:days 6 and 28—

Countries

Germany, Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)