Intensive Care UnitsSECU-BIO2NCT06349551
Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling.
An observational study of Intensive Care Units and Arterial Lines, run by Nantes University Hospital at 2 sites in France.
Trial summary
After blood sampling from an arterial catheter, the reinjection of the clearing fluid (a mixture of saline solution and blood) is proposed to limit blood loss. However, the status of coagulation in this clearing liquid remains poorly documented. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Intensive Care Units, Arterial Lines
- What is being tested?
- Patients of intensive care unit
- How many people
- 213 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Apr 2024to 21 May 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patient with arterial catheter (radial or femoral).
Who may be able to join
- Patient older than 18 years old
- Admitted to the ICU
- With a radial or femoral arterial catheter
- Requiring blood sampling
Who cannot join
- Presence of a non-standard extension line: any tubing other than an arterial line intended for this purpose.
- Constitutional or acquired hemorrhagic disease,
- Major biological thrombophilia (anti-phospholipid syndrome, homozygous mutation of factor II or V, protein C, S or antithrombin deficiency),
- Thromboembolic event in progress or < 6 months,
- Bacteremia within the last 48 hours,
- Previous study participation,
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- Pregnant or breast-feeding patient
- Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment
- Patient with no health insurance
- Patient under guardianship
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nantes university hospital
Nantes, Loire-atlantique, 44093
Hospital center
Saint-Nazaire, 44606
About this study
Official title: Clot Formation and Coagulation Factors Consumption Over Time in the Clearing Fluid After Arterial Catheter Blood Sampling in Critically Ill Adult Patients. Prospective Observational Study.
After blood sampling from an arterial catheter, the reinjection of the clearing fluid (a mixture of saline solution and blood) is proposed to limit blood loss. However, the status of coagulation in this clearing liquid remains poorly documented.
Read the detailed description
In the intensive care unit, blood sampling is mainly performed through an arterial catheter (radial or femoral artery). In addition to continuous arterial pressure monitoring, this provides an easy access to arterial blood without the need for venipuncture.
It is standard practice to first clear the arterial sampling line before drawing blood for biological tests, to prevent the blood sample from being diluted by the arterial catheter's perfusion solution. This clearing fluid (i.e., a mixture of saline solution and blood) is usually discarded. It has been reported that the clearing fluid volume alone represents 24 to 30% of the total blood volume required for blood sampling.
Devices for reinjecting this clearing fluid are already on the market. The advantages of these devices include blood saving, reduced risk of blood exposure, reduced biological waste and lower infection rates associated with catheter handling. The main drawback of these devices is their cost and the need for frequent replacement. Moreover, their impact on the decrease of blood transfusion remains unclear.
Furthermore, there are too few published data on the potential coagulation of clearing fluid reinjected into the patient nor the maximum time it can be safely reinjected.
The aim of this study is to assess the activation of coagulation over time in the clearing fluid during arterial catheter blood sampling
- Conditions
- Intensive Care Units, Arterial Lines
- Being tested
- Patients of intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients of intensive care unitBiological
Patients of intensive care unit having an arterial catheter undergoing arterial blood sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter
Activation of coagulation in the clearing fluid will be assessed by a composite criterion defined by:
- the presence of a macroscopic clot (binary YES or NO criterion) or
- fibrinogen consumption (binary YES or NO criterion). Fibrinogen consumption will be classified as YES when its decrease, compared with the reference value measured at T0, is greater than the known technical variability of the assay method
Measured: 5 minutes (T5)
Secondary outcomes (4)
Concentration of prothrombin over time in the clearing fluid during blood sampling from an arterial catheter
Prothrombin time will be assayed at T0, T3 and T5
Measured: 5 minutes (T5)
Concentration of factor II over time in the clearing fluid during blood sampling from an arterial catheter
Factor II will be assayed at T0, T3 and T5
Measured: 5 minutes (T5)
Concentration of factor V over time in the clearing fluid during blood sampling from an arterial catheter
Factor V will be assayed at T0, T3 and T5
Measured: 5 minutes (T5)
Concentration of fibrin monomer over time in the clearing fluid during blood sampling from an arterial catheter
Fibrin monomers will be assayed at T0, T3 and T5
Measured: 5 minutes (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start16 Apr 2024
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349551
- Sponsor's protocol ID
- RC23_0586
- Acronym
- SECU-BIO2
- Status last verified
- May 2025
- First submitted
- 20 Mar 2024
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clot Formation and Coagulation Factors Consumption Over Time in the Clearing Fluid After Arterial Catheter Blood Sampling in Critically Ill Adult Patients. Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06349551
- Acronym / sponsor ID
- SECU-BIO2 / RC23_0586
- Conditions
- Intensive Care Units, Arterial Lines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 5 Apr 2024 (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.
After blood sampling from an arterial catheter, the reinjection of the clearing fluid (a mixture of saline solution and blood) is proposed to limit blood loss. However, the status of coagulation in this clearing liquid remains poorly documented.
Detailed description
In the intensive care unit, blood sampling is mainly performed through an arterial catheter (radial or femoral artery). In addition to continuous arterial pressure monitoring, this provides an easy access to arterial blood without the need for venipuncture.
It is standard practice to first clear the arterial sampling line before drawing blood for biological tests, to prevent the blood sample from being diluted by the arterial catheter's perfusion solution. This clearing fluid (i.e., a mixture of saline solution and blood) is usually discarded. It has been reported that the clearing fluid volume alone represents 24 to 30% of the total blood volume required for blood sampling.
Devices for reinjecting this clearing fluid are already on the market. The advantages of these devices include blood saving, reduced risk of blood exposure, reduced biological waste and lower infection rates associated with catheter handling. The main drawback of these devices is their cost and the need for frequent replacement. Moreover, their impact on the decrease of blood transfusion remains unclear.
Furthermore, there are too few published data on the potential coagulation of clearing fluid reinjected into the patient nor the maximum time it can be safely reinjected.
The aim of this study is to assess the activation of coagulation over time in the clearing fluid during arterial catheter blood sampling
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patient with arterial catheter (radial or femoral).
Key inclusion criteria (4 listed)
- Patient older than 18 years old
- Admitted to the ICU
- With a radial or femoral arterial catheter
- Requiring blood sampling
Key exclusion criteria (10 listed)
- Presence of a non-standard extension line: any tubing other than an arterial line intended for this purpose.
- Constitutional or acquired hemorrhagic disease,
- Major biological thrombophilia (anti-phospholipid syndrome, homozygous mutation of factor II or V, protein C, S or antithrombin deficiency),
- Thromboembolic event in progress or < 6 months,
- Bacteremia within the last 48 hours,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients of intensive care unitPatients of intensive care unit having an arterial catheter undergoing arterial blood sampling | Biological | – |
Primary outcome
Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter
Time frame: 5 minutes (T5)
Activation of coagulation in the clearing fluid will be assessed by a composite criterion defined by: * the presence of a macroscopic clot (binary YES or NO criterion) or * fibrinogen consumption (binary YES or NO criterion). Fibrinogen consumption will be classified as YES when its decrease, compared with the reference value measured at T0, is greater than the known technical variability of the assay method
4 secondary outcomes
Concentration of prothrombin over time in the clearing fluid during blood sampling from an arterial catheter
Time frame: 5 minutes (T5)
Concentration of factor II over time in the clearing fluid during blood sampling from an arterial catheter
Time frame: 5 minutes (T5)
Concentration of factor V over time in the clearing fluid during blood sampling from an arterial catheter
Time frame: 5 minutes (T5)
Concentration of fibrin monomer over time in the clearing fluid during blood sampling from an arterial catheter
Time frame: 5 minutes (T5)
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 25 May 2025.
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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 Intensive Care Units and Arterial Lines, run by Nantes University Hospital at 2 sites in France.
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 4 inclusion and 10 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 25 May 2025. 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 France. 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?
Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter (time frame: 5 minutes (T5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.