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NCT04860544: RBCT
Is Red Blood Cell Transfusion a Risk Factor for Vascular Pedicle Thrombosis? The Study Case of a Latin American Cohort
trial testing RED BLOOD CELLS TRANFUSION in Vascular Thrombosis in 302 participants. Completed in 16 December 2019.
27 May 2019
Quick facts
| Lead sponsor | Fundación Universitaria de Ciencias de la Salud |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 302 |
| Start date | 16 January 2013 |
| Primary completion | 27 May 2019 |
| Estimated completion | 16 December 2019 |
Drugs / interventions tested
- RED BLOOD CELLS TRANFUSION
Conditions studied
- Vascular Thrombosis — all drugs for Vascular Thrombosis →
Sponsor
Fundación Universitaria de Ciencias de la Salud — full company profile →
Who can join
18 and older, any sex, with Vascular Thrombosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04860544
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04860544 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación Universitaria de Ciencias de la Salud
- Last refreshed: 5 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04860544.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing