Platelets in out of hospital cardiac arrest

Not Applicable

Completed

• Conditions: Out of hospital cardiac arrest, ST elevation myocardial infarction; Circulatory System

• Registration Number: ISRCTN34122839
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary

1. 2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28698333 (added 14/08/2019) 2. 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30716426 (added 14/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-09
• Study Completion: 2017-04-06
• Last Update Posted: 9 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

OHCA group:
Any individual admitted to the Emergency Department following OHCA with return of spontaneous circulation (ROSC), who meets the Utstein criteria will be enrolled immediately upon arrival. The Utstein group is an internationally defined cohort of individuals who have a witnessed cardiac arrest, likely due to a heart attack and have a specific heart rhythm (VF or pulseless VT) on arrival of the Emergency Medical Service.

For the STEMI group:
Any patient brought to the coronary catheter laboratory or ED deemed to be having a STEMI by the clinical team and offered primary PCI will be eligible for enrolment.

Exclusion Criteria

1. Patients currently detained by Her Majesty’s Prison Service
2. Patients detained under the Mental Capacity act
3. Patients known or suspected to be pregnant
4. Patients known to lack capacity, for example known to have dementia

The following OHCA patients will not be enrolled:
1. Patients who suffer an in-hospital cardiac arrest
2. Patients who arrive in ED in cardiac arrest and fail to achieve or maintain ROSC within 10 minutes
3. Patients who have an unwitnessed arrest, OR an initial rhythm that is not ventricular fibrillation or ventricular tachycardia OR have an obvious non-cardiological cause (and so fail to meet Utstein criteria)
4. Patients who have sustained ROSC but who it is felt will not benefit from admission to intensive care. The decision as to ICU suitability will be undertaken by the clinical team

With regard to the STEMI group:
1. Patients not meeting the ESC criteria for STEMI
2. Patients lacking capacity (as deemed by the clinical team)
3. Patients undergoing rescue PCI
4. Patients not offered primary PCI
5. Patients who have a period of cardiac arrest but regain consciousness

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coagulation and platelet function in Utstein cohort patients admitted to intensive care (ICU) after out of hospital cardiac arrest (OHCA), and how these change after routine medical interventions given to survivors of OHCA. The primary outcome will be measured via a combination of bedside thromboelastometric assessment of whole blood coagulation using the ROTEM® delta and platelet module and the biochemical analysis of plasma. The thromboelastometric analysis will be performed at five time points; immediately on admission, after the completion of percutaneous coronary intervention (PCI) and 12 hours, 24 hours and 48 hours post PCI. The serum from each time point will then be frozen and batch testing will occur at the end of the study.

Secondary Outcome Measures

Name	Time	Method
Rates of bleeding, blood transfusion and in-stent thrombosis within 30 days of admission by recording the instances and frequency of each occurrence (from medical notes review)