NCT06406920

Brief Summary

The scientific goals of the project:

  1. 1.ultrasound assessment of the incidence of clotting in deep veins in patients after cardiac arrest during resuscitation and after the declaration of death; comparison to the incidence of clotting in the heart cavities
  2. 2.comparison of resuscitation results in patients with and without clotting detected in deep veins during resuscitation
  3. 3.determining the time from cardiac arrest to the occurrence of clotting in deep veins; comparison to the time until clotting occurs in the heart cavities

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 29, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

March 24, 2024

Last Update Submit

May 7, 2024

Conditions

Keywords

cardiopulmonary resuscitation CPRpoint-of-care ultrasound POCUSintravascular clotting

Outcome Measures

Primary Outcomes (4)

  • Intravascular clotting during CPR

    The percentage of patients with intravascular clotting observed during cardioplumonary resuscitation.

    One year (preliminary data will be presented after 6 months.

  • Intravascular clotting after termination of CPR

    The percentage of patients with intravascular clotting observed after termination of CPR

    One year (preliminary data will be presented after 6 months.

  • Time from cardiac arrest to first clot during CPR

    Time from cardiac arrest to the first intravascular clot fromation during CPR

    One year (preliminary data will be presented after 6 months.

  • Time from cardiac arrest to first clot after termination of CPR.

    Time from cardiac arrest to the first intravascular clot fromation after termination of CPR.

    One year (preliminary data will be presented after 6 months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who experience cardiac arrest in the emergency department, regardless of the mechanism and cause. Patients who were declared dead after resuscitation after cardiac arrest that occurred in the emergency department

You may qualify if:

  • patients who experience cardiac arrest in the emergency department, regardless of the mechanism and cause
  • patients who were declared dead after resuscitation after cardiac arrest that occurred in the emergency department

You may not qualify if:

  • age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Centre - Clinical Emergency Department

Gdansk, Pomeranian Voivodeship, 80-214, Poland

RECRUITING

Related Publications (6)

  • Reynolds JC, Issa MS, C Nicholson T, Drennan IR, Berg KM, O'Neil BJ, Welsford M; Advanced Life Support Task Force of the International Liaison Committee on Resuscitation. Prognostication with point-of-care echocardiography during cardiac arrest: A systematic review. Resuscitation. 2020 Jul;152:56-68. doi: 10.1016/j.resuscitation.2020.05.004. Epub 2020 May 11.

    PMID: 32437781BACKGROUND
  • Jackowski C, Thali M, Aghayev E, Yen K, Sonnenschein M, Zwygart K, Dirnhofer R, Vock P. Postmortem imaging of blood and its characteristics using MSCT and MRI. Int J Legal Med. 2006 Jul;120(4):233-40. doi: 10.1007/s00414-005-0023-4. Epub 2005 Nov 19.

    PMID: 16328426BACKGROUND
  • Lau V, Blaszak M, Lam J, German M, Myslik F. Point-of-Care Resuscitative Echocardiography Diagnosis of Intracardiac Thrombus during cardiac arrest (PREDICT Study): A retrospective, observational cohort study. Resusc Plus. 2022 Mar 11;10:100218. doi: 10.1016/j.resplu.2022.100218. eCollection 2022 Jun.

    PMID: 35299826BACKGROUND
  • Clattenburg EJ, Wroe P, Brown S, Gardner K, Losonczy L, Singh A, Nagdev A. Point-of-care ultrasound use in patients with cardiac arrest is associated prolonged cardiopulmonary resuscitation pauses: A prospective cohort study. Resuscitation. 2018 Jan;122:65-68. doi: 10.1016/j.resuscitation.2017.11.056. Epub 2017 Nov 23.

    PMID: 29175356BACKGROUND
  • Scerrati A, Menegatti E, Zamboni M, Malagoni AM, Tessari M, Galeotti R, Zamboni P. Internal Jugular Vein Thrombosis: Etiology, Symptomatology, Diagnosis and Current Treatment. Diagnostics (Basel). 2021 Feb 23;11(2):378. doi: 10.3390/diagnostics11020378.

    PMID: 33672254BACKGROUND
  • Nolan JP, Berg RA, Andersen LW, Bhanji F, Chan PS, Donnino MW, Lim SH, Ma MH, Nadkarni VM, Starks MA, Perkins GD, Morley PT, Soar J; Utstein Collaborators. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Template for In-Hospital Cardiac Arrest: A Consensus Report From a Task Force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia). Resuscitation. 2019 Nov;144:166-177. doi: 10.1016/j.resuscitation.2019.08.021. Epub 2019 Sep 16.

    PMID: 31536777BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Robert K Szymczak, Asst. Prof.

    Medical University of Gdansk, Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert K Szymczak, Asst. Prof.

CONTACT

Mariusz Siemiński, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2024

First Posted

May 9, 2024

Study Start

April 29, 2024

Primary Completion

October 1, 2024

Study Completion

April 1, 2025

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations