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OpenTrials
Completed

NCT Number: NCT02914795

Platelet Function in Resuscitated Patients

Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath lab. Therapy usually consists of one or more stent implantations. After implantation of a coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, knowledge of the individual platelet function is valuable.

Several factors potentially promote a delayed or reduced mode of action of platelet function inhibitors in resuscitated patients:

1. oral administration is impossible and medication needs to be administered via a gastric line. 2. gastric absorption is delayed after resuscitation 3. according to current guidelines patients are treated with therapeutic hypothermia. Including the time of rewarming cooling period is ~48h

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Key information

About this study

Patients after successful resuscitation associated to a myocardial infarction will be included into the study the morning after the index event. Patients get dual platelet inhibition at the discretion of the interventionist. Patients are treated with therapeutic hypothermia according to the local Standard operating procedure for 24h and rewarming is performed within an additional 20h. Platelet function is measured every morning and Aspirin mediated as well as P2Y12 (purinergic G protein-coupled receptors-12)-inhibition mediated platelet function inhibition is recorded. All relevant clinical data including APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA ( Sequential Organ Failure Assessment score) scores are collected.

The degree of platelet inhibition over time (7 days) and differences between the three drugs tested will be evaluated by optical aggregometry and by using the commercial VerifyNow test system.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myocardial infarction
  • dual platelet inhibition
  • resuscitation
  • therapeutic hypothermia

Exclusion criteria

  • none

Treatment and study plan

diagnostic analysis of platelet function

Other

analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique

Primary outcomes

  1. Platelet Inhibition Measured With Optical Aggregometry

    Time frame: day 3

    Median (Inter-Quartile Range) Collagen AUC values on Day 3 measured with optical aggregometry The more light signal is detected, the better thrombocyte function is.

Secondary outcomes

  1. Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2016
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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