Artery Disease, PeripheralNCT04703582
Relationship Between Morbimortality and Basal Activated Clotting Time (ACT) in Patients Undergoing Vascular Surgery
An observational study of Artery Disease, Peripheral and Aortic Diseases, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
Check whether patients with higher comorbidity and risk of complication, estimated using the V (p) -POSSUM score, ACS NSQIP and the ASA classification, present higher baseline activated clotting time values. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Artery Disease, Peripheral, Aortic Diseases, Carotid Artery Diseases
- What is being tested?
- Activated clotting time
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jun 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing vascular surgery consecutively in the first semester of 2021, for a period of one month, will be included.
Who may be able to join
- Patients undergoing vascular surgery requiring intraoperative heparinization
Who cannot join
- Pregnant women
- SARS-CoV-2 PCR positive (performed 24-72h prior to surgery)
- Severe plaquetopenia <50,000
About this study
Check whether patients with higher comorbidity and risk of complication, estimated using the V (p) -POSSUM score, ACS NSQIP and the ASA classification, present higher baseline activated clotting time values.
- Being tested
- Activated clotting time
- Medical subject headings
- Peripheral Arterial Disease, Aortic Diseases, Carotid Artery Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated clotting timeDiagnostic test
Relationship between elongated baseline activated clotting time and comorbidity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on baseline Activated Clotting Time with comorbidities
Activted Clotting Time will be measured with Haemocron Machine just before surgery. Comorbidities will be measured with V(p)Possum, AC NSQUIP and ASA scales.
Measured: 1 day - surgery day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artery Disease, PeripheralStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703582
- Sponsor's protocol ID
- IIBSP-TCA-2020-92
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 11 Jan 2021
- 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 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Morbimortality and Basal Activated Clotting Time (ACT) in Patients Undergoing Vascular Surgery
- ClinicalTrials.gov ID
- NCT04703582
- Acronym / sponsor ID
- IIBSP-TCA-2020-92
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 11 Jan 2021 (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.
Check whether patients with higher comorbidity and risk of complication, estimated using the V (p) -POSSUM score, ACS NSQIP and the ASA classification, present higher baseline activated clotting time values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing vascular surgery consecutively in the first semester of 2021, for a period of one month, will be included.
Key inclusion criteria (1 listed)
- Patients undergoing vascular surgery requiring intraoperative heparinization
Key exclusion criteria (3 listed)
- Pregnant women
- SARS-CoV-2 PCR positive (performed 24-72h prior to surgery)
- Severe plaquetopenia <50,000
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 |
|---|---|---|
| Activated clotting timeRelationship between elongated baseline activated clotting time and comorbidity | Diagnostic test | – |
Primary outcome
Change on baseline Activated Clotting Time with comorbidities
Time frame: 1 day - surgery day
Activted Clotting Time will be measured with Haemocron Machine just before surgery. Comorbidities will be measured with V(p)Possum, AC NSQUIP and ASA scales.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Artery Disease, Peripheral and Aortic Diseases, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change on baseline Activated Clotting Time with comorbidities (time frame: 1 day - surgery day). 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 11 Jan 2021.