Relationship Between Morbimortality and Basal Activated Clotting Time (ACT) in Patients Undergoing Vascular Surgery

January 8, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients undergoing vascular surgery requiring intraoperative heparinization

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day - surgery day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-TCA-2020-92

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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