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Is Red Blood Cell Transfusion a Risk Factor for Vascular Pedicle Thrombosis? The Study Case of a Latin American Cohort

NCT04860544 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 302

Last updated 2021-05-05

No results posted yet for this study

Summary

The present cohort was performed between January of 2014 and December of 2019. It included 302 free flaps conducted between January 2006 and December 2019 in the Hospital de San José and Hospital Infantil Universitario de San José in Bogotá, Colombia. Its aims were to determine whether there is an association between perioperative red blood cell transfusion and the risk of free flap vascular pedicle thrombosis. The exposure was the red blood cell transfusion therapy during the perioperative eriod, and the primary outcome was the occurrence of vascular pedicle thrombosis, which was defined as the intraoperative visualization of arterial or venous thrombosis of the vascular pedicle observed until seven days following the procedure.

As a secondary outcome, the presence of clinical signs of arterial or venous flap suffering. Red blood cell transfusion was prescribed by the attending anesthesiologist.

The methodology included data collection from medical records history, statistical analysis (incidence of thrombosis and to plot survival curves, the incidence rates calculated for every 1000 free flaps and the analysis between thrombosis and perioperative variables) by Kaplan Meier method and Cox regression models and its interpretation. The results showed that red blood cell transfusion during the perioperative period did not represent a risk for vascular pedicle thrombosis and also discarded a possible effect on the free flap survival.

Conditions

  • Vascular Thrombosis

Interventions

PROCEDURE

RED BLOOD CELLS TRANFUSION

Sponsors & Collaborators

  • Hospital de San Jose

    collaborator OTHER

  • Fundación Universitaria de Ciencias de la Salud

    lead OTHER

Principal Investigators

  • CARLOS E TORRES FUENTES, MD.PS · FUNDACION UNIVERSITARIA DE CIENCIAS DE LA SALUD

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-16
Primary Completion
2019-05-27
Completion
2019-12-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860544 on ClinicalTrials.gov