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Thrombolysis for intra-hospital cardiac arrest related to pulmonary embolism-study design

Antoniu Octavian Petris, Gabriel Tatu-Chitoiu, Diana Cimpoesu, Irina Costache, Diana T

Background: Acute pulmonary embolism (PE) is a major cause of cardiac arrest with a high in-hospital mortality rate. If a fibrinolytic drug is given in these circumstances, survival and good neurological outcome have been reported in some cases although a study powered to reach significance has not yet been conducted.

Methods: We are planning a prospective, multicenter, double-blind, randomized study carried out in Emergency Department, Intensive Care Unit or hospital wards on assigned adult patients with witnessed in-hospital cardiac arrest induced by high risk pulmonary embolism (diagnosis by right heart dysfunction on Focused Echocardiographic in Emergency Life support - FEEL). Six centers will randomize 170 patients to receive either streptokinase or alteplase (1:1 ratio) during cardiopulmonary resuscitation (CPR).

Results: Primary endpoint of the study is the hospital discharge survival rate. Secondary endpoints are the return of spontaneous circulation, survival after 24 h, survival at 30 days, neurological performance (Cerebral Performance Categories), safety endpoints include major bleeding complications and intracranial hemorrhage.

Conclusions: Administration of the fibrinolytic drug immediately after CPR initiation in patients with cardiac arrest related to acute PE readily diagnosed using FEEL assessment and ensuring the continuation of resuscitative efforts for at least 60 min will provide statistically valid information about a topic which still relies on the experts' consensus.