Troponine-At-Bedside study

ISRCTN	ISRCTN92275378
DOI	https://doi.org/10.1186/ISRCTN92275378
Protocol serial number	00-035
Sponsor	Dade Behring (France)
Funder	The Henri Mondor Hospital (France)

Submission date: 04/08/2007
Registration date: 09/08/2007
Last edited: 29/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Bertrand Renaud
Scientific

GHU Henri Mondor-Albert Chenevier
51, avenue du Maréchal Delattre de Tassigny
Créteil
94010 Cedex
France

Study information

Primary study design	Interventional
Study design	Randomized controlled trial.
Secondary study design	Randomised controlled trial
Scientific title	Troponine-At-Bedside study
Study acronym	TAB
Study objectives	We hypothesized that Point of Care Testing in the emergency department for troponin I measurement would be associated with a faster process of care, including for patients presenting with non specific symptoms.
Ethics approval(s)	The Institutional Review Board for the Protection of Human Subjects of Henri Mondor Hospital approved the study protocol and patient informed consent procedures in June 2002.
Health condition(s) or problem(s) studied	Acute coronary syndrome
Intervention	Point-Of-Care testing in the emergency department vs central hospital laboratory testing for troponin I measurement.
Intervention type	Other
Primary outcome measure(s)	Time to anti-ischemic therapy.
Key secondary outcome measure(s)	1. Time to physician notification of troponin I level 2. Length of stay within the emergency department defined by the time to bed assignment 3. Mortality at 30 and 90 days after presentation 4. Level of emergency department staff reliability on Point-Of-Care testing versus central hospital laboratory testing as assessed by the proportion of second troponin I tests ordered after the Point-Of-Care testing
Completion date	31/07/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	800
Total final enrolment	833
Key inclusion criteria	1. Age 18 years or older 2. Suspicion of acute coronary syndrom 3. Required to measure troponin I (Ti)
Key exclusion criteria	1. Patients presenting with ST-elevation Acute Coronary Syndrome (ACS) (typical chest pain and persistent [>20 min] ST-segment elevation [>0.1 mV in limb leads or 0.2 mV in precordial leads]) did not represent such a diagnostic challenge compared to NSTE-ACS and were candidate for urgent reperfusion procedure, and therefore were excluded from the current analysis. Other exclusion criteria: 2. Refusal or inability to provide informed consent 3. Previous enrolment in the study Additionally, aiming to select patients with high risk ACS, the patients who had 1-2 Ti levels consistently <0.10 µg/L within eight hours of the onset of ACS symptoms were excluded from the study post-hoc.
Date of first enrolment	01/11/2002
Date of final enrolment	31/07/2004

Locations

Countries of recruitment

France

Study participating centre

GHU Henri Mondor-Albert Chenevier

Créteil
94010 Cedex
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		26/02/2008	29/10/2021	Yes	No

Editorial Notes

29/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.