Troica trial

In-hospital cardiac arrest, cardiac arrest of presumed noncardiac origin, obvious significant internal bleeding, known neurological impairment, known coagulation disorder, or known hypersensitivity to study medication. Return of spontaneous circulation, survival at 24 hours, survival to hospital discharge or day 30 whichever is first, and distribution of neurological and overall outcome scores. Patients were randomized to single bolus TNK 0.

Patients were randomized immediately after insertion of an intravenous line. CPR was to be administered for an additional 10 minutes after TNK bolus, and could continue for an additional 30 minutes as needed. A protocol amendment excluded patients with asystole from inclusion.

The trial was discontinued prematurely at the recommendation of the data safety monitoring board for futility. Subjects who meet any of the following criteria will be excluded from randomisation into the study:. Try the modernized ClinicalTrials. Learn more about the modernization effort.

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Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : October 29, Study Description. The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.

Detailed Description:. Study Hypothesis: The primary aim of the trial is to demonstrate superiority in the intent-to-treat analysis of tenecteplase over placebo with regard to primary endpoint as the incidence of day survival 30daysurv.

Drug Information available for: Tenecteplase. FDA Resources. Arms and Interventions. Outcome Measures. Primary Outcome Measures : The primary endpoint of this study is the day survival rate [ Time Frame: 30 days ] The co-primary endpoint of this study is hospital admission [ Time Frame: 30 days ].

Secondary Outcome Measures : Return of spontaneous circulation ROSC [ Time Frame: 30 days ] hr survival [ Time Frame: 24 hours ] Neurological and overall outcome at hospital discharge or at day 30, whichever came first [ Time Frame: 30 days ] Symptomatic intracranial haemorrhage ICH up to hospital discharge or day 30, whichever came first [ Time Frame: 30 days ] Major bleeds up to hospital discharge or day 30, whichever came first [ Time Frame: 30 days ].

In primary PEA, none of those obvious mechanical factors is present, and ventricular muscle fails to produce an effective contraction despite continued electrical activity. The proximate mechanism for failure of electromechanical coupling is abnormal intracellular calcium metabolism, intracellular acidosis and adenosine triphosphate depletion that can occur because of acute myocardial ischemia, which is the major cause of cardiac arrest, toxins, and electrolyte imbalance.

Diagnosis of an acute ischemic stroke is possible by echocardiographic evaluation of ventricular wall function but in the setting of cardiac arrest, it becomes difficult and requires more studies. The review of the literature reveals that transthoracic echocardiography is highly specific but not highly sensitive to detect pulmonary embolism and few prospective studies have been conducted to evaluate the accuracy of the transthoracic echocardiography to detect pulmonary emboli in a cardiac arrest setting 11 , In Breitkreutz et al.

So, diagnosis and treatment of these two main etiologies should also be considered when there are no directly related echocardiographic findings, but other etiologies are ruled out. In a randomized, multicenter TROICA trial, all patients with asystole and pulseless electrical activity immediately underwent thrombolytic therapy with tenecteplase alone. It showed no significant improvement in survival 13 but case reports and meta-analysis suggested using thrombolysis combined with heparin as a successful therapy during prolonged CPR in pulmonary thromboembolic PTE patients 14 , Perhaps applying a more selective strategy that specifies thrombolytic after using echocardiography and ruling out other reversible pathologies including pneumothorax, hypovolemia and tamponade improve survival.

Based on the pathophysiology for PEA arrest, the administration of calcium and adenosine might enhance cardiac contractility and increase the possibility of ROSC; as a result, physicians would have more time to carry out a precise work on the diagnosis of the underlying cause of arrest. There is a paucity of data on the use and possible appropriate timing of calcium administration in cardiac arrest in humans By recognizing that the most common mechanism of PEA arrest in trauma is mostly due to anoxic cardiac arrest rather than coronary occlusion, calcium probably has a benefit, especially in PEA patients with ventricular contractions.

Pulseless electrical activity, occult VF and asystole are similar on EKG but require different treatments. The application of echo during CPR has been used as a diagnostic aid in this issue, too. Case reports indicated the benefit of ultrasound to detect occult VF that appeared asystole on EKG and allowed proper treatment with defibrillation 18 , Now the questions are: Are there specific diagnostic ultrasound features to differentiate pseudo PEA vs.

Do pseudo-PEA patients benefit from performing shock? In further researches, it is important to draw a sharp distinction between ultrasound findings of ineffective cardiac motion in PEA vs.

The American Heart Association's Guidelines do not recommend shocking in asystole or PEA but applying electrical defibrillation in PEA arrest patients in the compensatory stage, when an ultrasound shows cardiac motion, might be a point for further research.

Application of ultrasound in pulseless electrical activity PEA cardiac arrest. National Center for Biotechnology Information , U. Med J Islam Repub Iran. Author information Article notes Copyright and License information Disclaimer. Received Sep 9; Accepted Feb This is an open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3. References 1.