Drug MonitoringPlasma ConcentNCT07917455
Plasma Concentration Monitoring of Direct Oral Anticoagulants in Emergency Department Patients: Comparison of Two Laboratory Methods
An observational study of Drug Monitoring and Anticoagulants, run by Istituti Clinici Scientifici Maugeri SpA at 2 sites in Italy.
Trial summary
The goal of this observational study is to learn whether two laboratory tests give the same results when measuring blood levels of blood thinners. The study looked at adults who take direct oral anticoagulants (DOACs) and came to an emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Monitoring, Anticoagulants, Factor Xa Inhibitors
- How many people
- 142 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Convenience sample of adults on chronic DOAC therapy who came to the Emergency Department of Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, between June 2024 and 2025.
Who may be able to join
- Chronic therapy with a direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban)
- Access to the Emergency Department of Fondazione IRCCS Policlinico San Matteo, Pavia, for any reason
- Signed informed consent
Who cannot join
- Unknown time between last DOAC intake and Emergency Department access
- Missing other essential study data
- Repeated Emergency Department access by a person already enrolled in the study
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Istituti Clinici Scientifici Maugeri, IRCCS
Pavia, Lombardy, 27100
About this study
Official title: Monitoring of Direct Oral Anticoagulant (DOAC) Plasma Concentrations in Patients Presenting to the Emergency Department: Comparison Between Direct (LC-MS/MS) and Indirect (Chromogenic) Methods and Clinical Interpretation. A Prospective Observational Study
The goal of this observational study is to learn whether two laboratory tests give the same results when measuring blood levels of blood thinners. The study looked at adults who take direct oral anticoagulants (DOACs) and came to an emergency department. DOACs are blood thinners such as apixaban, dabigatran, edoxaban and rivaroxaban.
Doctors do not usually measure DOAC levels in the blood. In an emergency, though, knowing the level can help doctors decide on treatment. This matters, for example, when a person is bleeding or has a blood clot.
Read more
The main questions the study aims to answer are:
- Do a standard hospital test and a more precise reference test give similar DOAC levels?
- How many participants have DOAC levels that are too low, normal or too high?
- Are levels that are too low or too high linked to emergency visits for bleeding or blood clots?
Participants:
- gave one blood sample when they arrived at the emergency department
- received their usual care, with no change to their treatment
Researchers measured the DOAC level in each sample with both tests. They also collected information from medical records, such as the reason for the visit and the time since the last DOAC dose.
Read the detailed description
At Emergency Department admission, a dedicated blood sample (plain tube, without anticoagulant or gel separator) was collected from each participant. DOAC concentration was measured with two methods:
- Indirect method: chromogenic anti-factor IIa (dabigatran) or anti-factor Xa (apixaban, edoxaban, rivaroxaban) assays, performed at the laboratory of Fondazione IRCCS Policlinico San Matteo.
- Direct method: validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS), performed at the Toxicology Laboratory of Istituti Clinici Scientifici Maugeri, Pavia. Serum was stored at -80°C until analysis.
Clinical data were collected from medical records using a dedicated case report form: demographics, medical history, concomitant medications, DOAC type, indication and daily dose, reason for ED access, time since last DOAC intake, routine laboratory tests (blood count, creatinine, AST, ALT, INR, PT, aPTT), treatment (including antidotes) and outcome of the acute episode. No follow-up was performed.
DOAC levels were classified as below, within or above the expected range for each drug. Agreement between methods was assessed with the intraclass correlation coefficient (ICC) with 95% confidence interval and Bland-Altman plots. Associations between DOAC level categories and ED access for coagulation-related problems were analyzed with chi-square or Fisher's exact test and univariable and multivariable logistic regression. The sample size was calculated to estimate an expected ICC of 0.75 with a 95% confidence interval width of 0.15.
- Conditions
- Drug Monitoring, Anticoagulants, Factor Xa Inhibitors, Direct Oral Anticoagulants (DOACs), Plasma Concentration
- Keywords
- therapeutic drug monitoring, Real-world setting, Direct oral anticoagulants, LC-MS/MS, Anti-Xa assay, DOAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults on chronic DOAC therapy presenting to the Emergency Department | People on chronic therapy with apixaban, dabigatran, edoxaban or rivaroxaban who came to the Emergency Department of Fondazione IRCCS Policlinico San Matteo for any reason. Each participant gave one blood sample at arrival, analyzed with both laboratory methods. Clinical care was not changed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between DOAC plasma concentrations measured by chromogenic assay and by HPLC-MS/MS
Intraclass correlation coefficient (ICC, unitless, range 0 to 1) between DOAC plasma concentrations (ng/mL) measured in the same blood sample with a DOAC-specific chromogenic anti-factor IIa/anti-factor Xa assay and with high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Higher values indicate better agreement.
Measured: Day 1
Secondary outcomes (4)
DOAC plasma concentration measured by chromogenic assay
Plasma concentration (ng/mL) of apixaban, dabigatran, edoxaban or rivaroxaban measured with a DOAC-specific chromogenic anti-factor IIa (dabigatran) or anti-factor Xa (apixaban, edoxaban, rivaroxaban) assay.
Measured: Day 1
DOAC plasma concentration measured by HPLC-MS/MS
Plasma concentration (ng/mL) of apixaban, dabigatran, edoxaban or rivaroxaban measured with a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method.
Measured: Day 1
Percentage of participants with DOAC plasma concentrations below, within or above the expected range
Percentage of participants whose DOAC plasma concentration, measured by HPLC-MS/MS, falls below, within or above the expected on-treatment range for the specific drug, dose and sampling time (peak or trough).
Measured: Day 1
Percentage of participants with Emergency Department access for bleeding or thrombosis
Percentage of participants whose reason for Emergency Department access was a coagulation-related problem (major or minor bleeding, or thrombosis), as recorded in the medical record, reported by DOAC plasma concentration category (below, within or above the expected range).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start10 Jun 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug MonitoringStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917455
- Sponsor's protocol ID
- DOAC_LAB
- Acronym
- Plasma Concent
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly, as the informed consent did not include data sharing and in compliance with the EU General Data Protection Regulation (GDPR). Aggregate results will be published in a peer-reviewed journal.
Publications
Gosselin RC, Adcock DM, Bates SM, Douxfils J, Favaloro EJ, Gouin-Thibault I, Guillermo C, Kawai Y, Lindhoff-Last E, Kitchen S. International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants. Thromb Haemost. 2018 Mar;118(3):437-450. doi: 10.1055/s-0038-1627480. Epub 2018 Feb 12.
PubMed 29433148
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Direct Oral Anticoagulant (DOAC) Plasma Concentrations in Patients Presenting to the Emergency Department: Comparison Between Direct (LC-MS/MS) and Indirect (Chromogenic) Methods and Clinical Interpretation. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07917455
- Acronym / sponsor ID
- Plasma Concent / DOAC_LAB
- Conditions
- Drug Monitoring, Anticoagulants, Factor Xa Inhibitors, Direct Oral Anticoagulants (DOACs), Plasma Concentration
- Keywords
- therapeutic drug monitoring, Real-world setting, Direct oral anticoagulants, LC-MS/MS, Anti-Xa assay, DOAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn whether two laboratory tests give the same results when measuring blood levels of blood thinners. The study looked at adults who take direct oral anticoagulants (DOACs) and came to an emergency department. DOACs are blood thinners such as apixaban, dabigatran, edoxaban and rivaroxaban.
Doctors do not usually measure DOAC levels in the blood. In an emergency, though, knowing the level can help doctors decide on treatment. This matters, for example, when a person is bleeding or has a blood clot.
The main questions the study aims to answer are:
- Do a standard hospital test and a more precise reference test give similar DOAC levels?
- How many participants have DOAC levels that are too low, normal or too high?
- Are levels that are too low or too high linked to emergency visits for bleeding or blood clots?
Participants:
- gave one blood sample when they arrived at the emergency department
- received their usual care, with no change to their treatment
Researchers measured the DOAC level in each sample with both tests. They also collected information from medical records, such as the reason for the visit and the time since the last DOAC dose.
Detailed description
At Emergency Department admission, a dedicated blood sample (plain tube, without anticoagulant or gel separator) was collected from each participant. DOAC concentration was measured with two methods:
- Indirect method: chromogenic anti-factor IIa (dabigatran) or anti-factor Xa (apixaban, edoxaban, rivaroxaban) assays, performed at the laboratory of Fondazione IRCCS Policlinico San Matteo.
- Direct method: validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS), performed at the Toxicology Laboratory of Istituti Clinici Scientifici Maugeri, Pavia. Serum was stored at -80°C until analysis.
Clinical data were collected from medical records using a dedicated case report form: demographics, medical history, concomitant medications, DOAC type, indication and daily dose, reason for ED access, time since last DOAC intake, routine laboratory tests (blood count, creatinine, AST, ALT, INR, PT, aPTT), treatment (including antidotes) and outcome of the acute episode. No follow-up was performed.
DOAC levels were classified as below, within or above the expected range for each drug. Agreement between methods was assessed with the intraclass correlation coefficient (ICC) with 95% confidence interval and Bland-Altman plots. Associations between DOAC level categories and ED access for coagulation-related problems were analyzed with chi-square or Fisher's exact test and univariable and multivariable logistic regression. The sample size was calculated to estimate an expected ICC of 0.75 with a 95% confidence interval width of 0.15.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults on chronic DOAC therapy presenting to the Emergency Department | – | –People on chronic therapy with apixaban, dabigatran, edoxaban or rivaroxaban who came to the Emergency Department of Fondazione IRCCS Policlinico San Matteo for any reason. Each participant gave one blood sample at arrival, analyzed with both laboratory methods. Clinical care was not changed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sample of adults on chronic DOAC therapy who came to the Emergency Department of Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, between June 2024 and 2025.
Key inclusion criteria (3 listed)
- Chronic therapy with a direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban)
- Access to the Emergency Department of Fondazione IRCCS Policlinico San Matteo, Pavia, for any reason
- Signed informed consent
Key exclusion criteria (3 listed)
- Unknown time between last DOAC intake and Emergency Department access
- Missing other essential study data
- Repeated Emergency Department access by a person already enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between DOAC plasma concentrations measured by chromogenic assay and by HPLC-MS/MS
Time frame: Day 1
Intraclass correlation coefficient (ICC, unitless, range 0 to 1) between DOAC plasma concentrations (ng/mL) measured in the same blood sample with a DOAC-specific chromogenic anti-factor IIa/anti-factor Xa assay and with high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Higher values indicate better agreement.
4 secondary outcomes
DOAC plasma concentration measured by chromogenic assay
Time frame: Day 1
DOAC plasma concentration measured by HPLC-MS/MS
Time frame: Day 1
Percentage of participants with DOAC plasma concentrations below, within or above the expected range
Time frame: Day 1
Percentage of participants with Emergency Department access for bleeding or thrombosis
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 29433148Gosselin RC, Adcock DM, Bates SM, Douxfils J, Favaloro EJ, Gouin-Thibault I, Guillermo C, Kawai Y, Lindhoff-Last E, Kitchen S. International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants. Thromb Haemost. 2018 Mar;118(3):437-450. doi: 10.1055/s-0038-1627480. Epub 2018 Feb 12.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly, as the informed consent did not include data sharing and in compliance with the EU General Data Protection Regulation (GDPR). Aggregate results will be published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Monitoring and Anticoagulants, run by Istituti Clinici Scientifici Maugeri SpA at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between DOAC plasma concentrations measured by chromogenic assay and by HPLC-MS/MS (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07917455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.