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

Red Blood Cell Transfusion and Its Association With Vascular Pedicle Thrombosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04860544
Acronym
RBCT
Enrollment
302
Registered
2021-04-27
Start date
2013-01-16
Completion date
2019-12-16
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Thrombosis

Keywords

Free flap, Thrombosis, Blood transfusion

Brief 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.

Detailed description

The study included patients who underwent free flap surgery between January 2006 and December 2019 in the Hospital de San José and Hospital Infantil Universitario de San José in Bogotá, Colombia. Criteria for exclusion were history of deep vein thrombosis, pulmonary embolism, systemic lupus erythematosus, antiphospholipid syndrome, hypercoagulability syndrome, and previous medication with oral or parenteral anticoagulant within the past year of the surgery. A standardized Google App for Work form was created where participant's medical records were registered. The exposure criteria were RBCT, and the primary outcome was the occurrence of VPT, which was defined as the intraoperative visualization of arterial or venous thrombosis in the vascular pedicle, observed up until seven days after the procedure. As a secondary outcome, the presence of clinical signs of arterial flap suffering (pallor, decreased capillary filling time, decreased skin turgor, , venous congestion: blue dermal bleeding, and poikilothermia). As well as the absence of blood flow measured by Doppler ultrasound that was registered from the beginning until the outcome. Different clinical characteristics were recorded such as: age, gender, body mass index (BMI), diabetes (fasting blood glucose \>126 mg/dl or random glucose value \>200 mg/dl), arterial hypertension (persistently high value \>140/90 mmHg or use of antihypertensive medication for adequate control) anesthetic risk (ASA Classification), most recent pre-surgical hemoglobin (Hb mg/dl), most recent pre-surgical hematocrit (Ht %), anemia (Hb \<12mg/dl or Hto \<36% in children under 14 and women of childbearing age, Hb \<13 mg/dl or Hto \<39% in men over 14 or postmenopausal women), history of chemotherapy during the past year, history of radiation therapy in the flap donor or free flap recipient site In regard to the surgery performed, the following variables were analyzed: indication of procedure, free flap donor site, free flap recipient site, type of flap, whether or not other concomitant surgical procedures were being performed (oncological resections, osteosynthesis, tumor resections) and intra-operative bleeding according to the records from anesthesiologists' evaluations. The information was exported from the standardized formats to a database for statistical analysis through statistical packages R and Stata 15® licensed by the Fundación Universitaria de Ciencias de la Salud - FUCS. The exposed group corresponded to patients who received red blood cell transfusion during the perioperative period of free flap surgery (defined as: 24 hours before, during and up to 24 hours after the procedure). \- The unexposed group corresponded to patients who did not receive red blood cell transfusion during the perioperative period of free flap surgery (defined as: 24 hours before, during and up to 24 hours after the procedure).

Interventions

PROCEDURERED BLOOD CELLS TRANFUSION

Sponsors

Hospital de San Jose
CollaboratorOTHER
Fundación Universitaria de Ciencias de la Salud
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The study included patients who underwent free flap surgery between January 2006 and December 2019 in the Hospital de San José and Hospital Infantil Universitario de San José in Bogotá, Colombia.

Exclusion criteria

* Criteria for exclusion were history of deep vein thrombosis, pulmonary embolism, systemic lupus erythematosus, antiphospholipid syndrome, hypercoagulability syndrome and previous medication with oral or parenteral anticoagulant within the past year of the surgery.

Design outcomes

Primary

MeasureTime frameDescription
VASCULAR PEDICLE THROMBOSIS7 DAYSthe primary outcome was the occurrence of VPT, which was defined as the intraoperative visualization of arterial or venous thrombosis of the vascular pedicle observed until seven days following the procedure

Secondary

MeasureTime frameDescription
arterial or venous non-thrombotic vascular complications in the flap7 DAYSAs a secondary outcome, the presence of clinical signs of arterial flap suffering (pallor, decreased capillary filling time, decreased skin turgor, scarce dermal bleeding and poikilothermia) or venous flap suffering (cutaneous cyanosis, increased turgor, venous congestion: blue dermal bleeding, and poikilothermia). As well as the absence of blood flow measured by Doppler ultrasound was registered from the beginning until the outcome

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026