NCT04703582

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 4, 2021

Last Update Submit

January 8, 2021

Conditions

Artery Disease, PeripheralAortic DiseasesCarotid Artery DiseasesOther Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day - surgery day

Interventions

Activated clotting timeDIAGNOSTIC_TEST

Relationship between elongated baseline activated clotting time and comorbidity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing vascular surgery consecutively in the first semester of 2021, for a period of one month, will be included.

You may qualify if:

  • Patients undergoing vascular surgery requiring intraoperative heparinization

You may not qualify if:

  • Pregnant women
  • SARS-CoV-2 PCR positive (performed 24-72h prior to surgery)
  • Severe plaquetopenia \<50,000

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Arterial DiseaseAortic DiseasesCarotid Artery DiseasesDisease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 11, 2021

Study Start

January 1, 2021

Primary Completion

March 1, 2021

Study Completion

June 1, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01