Bradykinin Receptor Antagonism During Cardiopulmonary Bypass

What Was Tested

The trial (phase 2, phase 3) is built around Icatibant.

Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB).

It had three arms (groups): HOE 140 (experimental), Aminocaproic Acid (active comparator) and Placebo (placebo comparator).

Bradykinin receptor antagonist.

Antifibrinolytic.

Placebo.

The registry classes the interventions as drug.

More on the Plan

Each year more than a million patients worldwide undergo cardiac surgery.

Nearly all cardiac surgeries are performed on unbeating hearts supported by CPB.

CPB activates various humoral cascades including the coagulation cascade, the KKS, the fibrinolytic cascade, and causes a systemic inflammatory response syndrome.

Activation of these systems can lead to hypotension, fever, disseminated intravascular coagulation, diffuse tissue edema, or, in extreme cases, to multiple organ failure.

Who Took Part

Enrollment: 150 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects, 18 to 80 years of age, scheduled for elective CABG requiring CPB. For female subjects, the following conditions must be met:.

The full record lists 2 inclusion and 13 exclusion criteria; among the exclusions: evidence of coagulopathy (inr greater than 1.7 without warfarin therapy); GPIIb/IIIa antagonist within 48 hours of surgery; emergency surgery.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Icatibant and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Icatibant study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2006-05 with completion listed for 2012-06.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Allogenic Blood Product Transfusion Risk (time frame: Patients were followed for the duration of hospital stay, an average of 6 days).

It also tracked 4 secondary outcomes, for example Units of Packed Red Blood Cells Transfused During Hospitalization, Units of Plasma Transfused During Hospitalization, Inflammatory Response as Measured by Interleukin-6 and Fibrinolytic Response as Measured by D-dimer.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Icatibant in 150 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Icatibant compound page, all human trials.