The impact of prehospital blood sampling on the emergency department process of patients with chest pain, a pragmatic non-randomized controlled trial
| ISRCTN | ISRCTN80335325 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80335325 |
| Secondary identifying numbers | Z19-024 |
- Submission date
- 05/01/2022
- Registration date
- 09/01/2022
- Last edited
- 13/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Current plain English summary as of 03/05/2022:
Background and study aims
In patients with acute chest pain who arrive at the emergency department (ED) by ambulance, venous access is frequently established prehospital, and could be utilized to sample blood. Prehospital blood sampling may save time in the diagnostic process, which may ultimately improve clinical outcome. In our study, we assessed whether prehospital blood draw is independently associated with shorter blood sample arrival times at the laboratory, shorter troponin turnaround times, and shorter ED length of stay (LOS) in patients with chest pain without abnormalities at their ECG, arriving at the ED by ambulance for cardiology. Our hypothesis was that prehospital blood draw shortens all three time intervals, potentially expediting care for chest pain patients without abnormalities at their ECG.
Who can participate?
All adult patients who were transported to the ED by ambulance with chest pain and no abnormalities at their prehospital ECG.
What does the study involve?
We assessed the three time intervals in patients who were transported to the ED with chest pain without abnormalities at their prehospital electrocardiogram. Time intervals were compared between cases, in whom prehospital blood draw was performed, and controls, in which blood drawn was performed at the ED. We assessed the association of prehospital blood draw with blood sample arrival times, troponin turnaround times, and ED LOS using multivariate analyses. We also compared blood sample mix-ups and blood sample quality (number of hemolysis and insufficient blood) between cases and controls.
What are the possible benefits and risks of participating?
There are no risks. Possible benefits were shorter waiting times before results of blood are available, and shorter length of stay at the emergency department.
Where is the study run from?
The study ran from an inner-city hospital in the Hague, the Netherlands and the Emergency Medical Service in the Hague.
When is the study starting and how long is it expected to run for?
January 2019 to February 2020.
Who is funding the study?
This study was funded by a grant from the Research Fund of Haaglanden Medical Centre (Netherlands). The funding source had no involvement in the study design, the collection, analysis and interpretation of the data, nor in the writing of the report and in the decision to submit the article for publication.
Who is the main contact?
Christien van der Linden, PhD, c.van.der.linden@haaglandenmc.nl
Previous plain English summary:
Background and study aims
In patients with acute chest pain who arrive at the emergency department (ED) by ambulance, venous access is frequently established prehospital, and could be utilized to sample blood. Prehospital blood sampling may save time in the diagnostic process, which may ultimately improve clinical outcome. In our study, we assessed whether prehospital blood draw is independently associated with shorter blood sample arrival times at the laboratory, shorter troponin turnaround times, and shorter ED length of stay (LOS) in patients with chest pain without ST-segment elevation myocardial infarction (STEMI), arriving at the ED by ambulance. Our hypothesis was that prehospital blood draw shortens all three time intervals, potentially expediting care for chest pain patients without STEMI.
Who can participate?
All adult patients who were transported to the ED by ambulance with chest pain and no ST-elevation at their prehospital ECG.
What does the study involve?
We assessed the three time intervals in patients who were transported to the ED with chest pain without STEMI at their prehospital electrocardiogram. Time intervals were compared between cases, in whom prehospital blood draw was performed, and controls, in which blood drawn was performed at the ED. We assessed the association of prehospital blood draw with blood sample arrival times, troponin turnaround times, and ED LOS using multivariate analyses.
What are the possible benefits and risks of participating?
There are no risks. Possible benefits were shorter waiting times before results of blood are available, and shorter length of stay at the emergency department.
Where is the study run from?
The study ran from an inner-city hospital in the Hague, the Netherlands and the Emergency Medical Service in the Hague.
When is the study starting and how long is it expected to run for?
January 2019 to February 2020.
Who is funding the study?
This study was funded by a grant from the Research Fund of Haaglanden Medical Centre (Netherlands). The funding source had no involvement in the study design, the collection, analysis and interpretation of the data, nor in the writing of the report and in the decision to submit the article for publication.
Who is the main contact?
Christien van der Linden, PhD, c.van.der.linden@haaglandenmc.nl
Contact information
Principal Investigator
P.O.Box 432
The Hague
2501CK
Netherlands
 ORCID ID |
0000-0002-0637-7875 |
|---|---|
| Phone | +31(0)650651825 |
| c.van.der.linden@haaglandenmc.nl |
Study information
| Study design | Pragmatic non-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | In patients who are transported to the emergency department with chest pain and no abnormalities at their prehospital ECG, what are the blood sample arrival times, troponin turnaround times, and length of stay of patients in whom prehospital blood draw is performed compared with controls in whom blood draw is performed at the emergency department? BCLOSED (Blooddraw Chestpain patients, impact on Length Of Stay at the Emergency Department) |
| Study acronym | B-CLOSED |
| Study objectives | Current study hypothesis: Prehospital blood draw shortens all three time intervals, potentially expediting care for chest pain patients with no abnormalities at their ECG. Previous study hypothesis: Prehospital blood draw shortens all three time intervals, potentially expediting care for chest pain patients without STEMI. |
| Ethics approval(s) | Approved 21/08/2019, Regional medical research committee Southwest Holland (METC-LDD, Albinusdreef 2, Postbus 9600, 2300 RC Leiden, Netherlands; +31(0)71-5263241; metc-ldd@lumc.nl), ref: 19-024, METC LDD |
| Health condition(s) or problem(s) studied | Patients with chest pain without abnormalities at their ECG, arriving at the ED by ambulance for cardiology |
| Intervention | Current interventions as of 03/05/2022: We conducted a pragmatic non-randomized controlled trial, comparing chest pain patients who underwent prehospital blood sampling with chest pain patients who were also brought in by ambulance, but in whom blood was drawn in the ED. The single-centre study took place at an ED in an inner-city teaching hospital and an EMS in The Hague, the Netherlands over a 5-month period (October 1, 2019 to February 29, 2020). Patients were eligible for inclusion in our study when they had chest pain as chief complaint, had no abnormalities at their prehospital ECG, were 18 years or older, and were brought to the ED for cardiology with ambulance urgency level A2. Upon arrival at the ED, patients are triaged according to the Manchester Triage System (MTS). Only the patients who were assigned to triage level 2 (very urgent) according to the MTS were included in the study. Patients who died at the ED, patients who left the ED against medical advice, and patients who were transferred to another facility were excluded from the study. Of patients with more than one ED visit during the study period, only the first ED visit was included. Participating ambulance nurses approached the patients who fulfilled the inclusion criteria for informed consent, while the patient was lying in the ambulance. After the patients’ consent, blood sampling was performed by the ambulance nurse. The participating EMS nurses performed blood draws only in combination with the insertion of a PIVC. No changes were made in the procedure for obtaining blood specimen in the ED: the blood sample was obtained through venepuncture or by drawing blood through a previously inserted PIVC (usual practice). The laboratory procedures for processing blood samples remained unchanged. Previous interventions: We conducted a non-randomized controlled trial, comparing chest pain patients who underwent prehospital blood sampling with chest pain patients who were also brought in by ambulance, but in whom blood was drawn in the ED. The single-centre study took place at an ED in an inner-city teaching hospital and an EMS in The Hague, the Netherlands over a 5-month period (October 1, 2019 to February 29, 2020). Patients were eligible for inclusion in our study when they had chest pain as chief complaint, had no ST-segment elevation at their prehospital ECG, were 18 years or older, and were brought to the ED with ambulance urgency level A2. Upon arrival at the ED, patients are triaged according to the Manchester Triage System (MTS). Only the patients who were assigned to triage level 2 (very urgent) according to the MTS were included in the study. Patients who died at the ED, patients who left the ED against medical advice, and patients who were transferred to another facility were excluded from the study. Of patients with more than one ED visit during the study period, only the first ED visit was included. Participating ambulance nurses approached the patients who fulfilled the inclusion criteria for informed consent, while the patient was lying in the ambulance. After the patients’ consent, blood sampling was performed by the ambulance nurse. The participating EMS nurses performed blood draws only in combination with the insertion of a PIVC. No changes were made in the procedure for obtaining blood specimen in the ED: the blood sample was obtained through venepuncture or by drawing blood through a previously inserted PIVC (usual practice). The laboratory procedures for processing blood samples remained unchanged. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | All measured retrospectively: 1. Patient demographics: age and gender measured using hospital information system, through query 2. Patients’ medical history and risk factors for cardiac ischemic events (smoking history, diabetes mellitus, hypertension, dyslipidemia, prior cardiovascular disease, family history coronary disease) measured using reviewing patient notes in the hospital information system 3. Arrival time measured using hospital information system, through query 4. Troponin values measured using reviewing patient notes in the hospital information system 5. Whether or not the patient underwent radiology tests measured using hospital information system, through query 6. Disposition measured using hospital information system, through query 7. Time intervals: Blood sample arrival times at the laboratory were defined as the duration between patient arrival at the ED and blood sample arrival at the laboratory. Troponin turnaround time was defined as time between patient arrival at the ED and the availability of the troponin result in the hospital information system. ED LOS was defined as the time between the patient’s presentation at the ED and the time the patient left the ED to be admitted or discharged home measured using measured using hospital information system, through query 8. Whether the patient arrived during extreme busyness at the ED was measured with the NEDOCS, the National ED OverCrowding Score, a multidimensional scale to measure patient volume and hospital throughput measured using hospital information system, through query |
| Secondary outcome measures | Current secondary outcome measures as of 03/05/2022: 1. Number of blood sample mix-ups 2. Blood sample quality (hemolysis and insufficient blood) Previous secondary outcome measures: There are no secondary outcome measures |
| Overall study start date | 01/01/2019 |
| Completion date | 29/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 196 |
| Total final enrolment | 506 |
| Key inclusion criteria | Current inclusion criteria as of 03/05/2022: 1. Patients with chest pain and no abnormalities at their ECG 2. Adult (18 years and older) 3. Transported by ambulance 4. Triage level 2 (orange) 5. Assessment by cardiology Previous inclusion criteria: 1. Patients with chest pain and no ST-elevation at their ECG 2. Adult (18 years and older) 3. Transported by ambulance 4. Triage level 2 (orange) |
| Key exclusion criteria | 1. Age <18 years 2. Not fulfilling inclusion criteria |
| Date of first enrolment | 01/10/2019 |
| Date of final enrolment | 29/02/2020 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
The Hague
2501CK
Netherlands
Sponsor information
Hospital/treatment centre
P.O.Box 432
The Hague
2501CK
Netherlands
| Phone | +31(0)889791626 |
|---|---|
| samantha.vink@landsteiner.nl |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The dataset used and analysed during the current study is available from the corresponding author on reasonable request. c.van.der.linden@haaglandenmc.nl |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/02/2024 | Yes | No |
Editorial Notes
13/02/2024: Publication reference added.
03/05/2022: The following changes were made to the trial record:
1. The public title was changed from "The impact of prehospital blood sampling on the emergency department process of patients with chest pain" to "The impact of prehospital blood sampling on the emergency department process of patients
with chest pain, a pragmatic non-randomized controlled trial".
2. The scientific title was changed from "In patients who are transported to the emergency department with chest pain and no ST-elevation at their prehospital ECG, what are the blood sample arrival times, troponin turnaround times, and length of stay of patients in whom prehospital blood draw is performed compared with controls in whom blood draw is performed at the emergency department? B-CLOSED (Blooddraw Chest pain patients, impact on Length Of Stay at the Emergency Department)" to "In patients who are transported to the emergency department with chest pain and no abnormalities at their prehospital ECG, what are the blood sample arrival times, troponin turnaround times, and length of stay of patients in whom prehospital blood draw is performed compared with controls in whom blood draw is performed at the emergency department? BCLOSED (Blooddraw Chestpain patients, impact on Length Of Stay at the Emergency Department)".
3. The study hypothesis was changed.
4. The study design was changed from "Interventional non-randomized controlled trial" to "Pragmatic non-randomized controlled trial".
5. The condition was changed from "Patients with chest pain without ST-segment elevation myocardial infarction (STEMI), arriving at the ED by ambulance; impact of prehospital blooddraw on ED length of stay" to "Patients with chest pain without abnormalities at their ECG, arriving at the ED by ambulance for cardiology".
6. The interventions were changed.
7. The secondary outcome measures were changed.
8. The inclusion criteria were changed.
9. The plain English summary was updated to reflect these changes.
07/01/2022: Trial's existence confirmed by Regional medical research committee Southwest Holland.
