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

NCT04860544 | Completed

• 1 other identifier: 462-3762-17
• Study Type: observational
• Target: 302
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vascular Thrombosis

Keywords

Free flap; Thrombosis; Blood transfusion

Outcome Measures

Primary Outcomes (1)

• VASCULAR PEDICLE THROMBOSIS

  the 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

  7 DAYS

Secondary Outcomes (1)

• arterial or venous non-thrombotic vascular complications in the flap

  7 DAYS

Interventions

RED BLOOD CELLS TRANFUSION PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Fundación Universitaria de Ciencias de la Salud: lead
• Hospital de San Jose: collaborator

Related Publications (7)

• Hill JB, Patel A, Del Corral GA, Sexton KW, Ehrenfeld JM, Guillamondegui OD, Shack RB. Preoperative anemia predicts thrombosis and free flap failure in microvascular reconstruction. Ann Plast Surg. 2012 Oct;69(4):364-7. doi: 10.1097/SAP.0b013e31823ed606.

  PMID: 22964664 BACKGROUND

• Kroll SS, Schusterman MA, Reece GP, Miller MJ, Evans GR, Robb GL, Baldwin BJ. Choice of flap and incidence of free flap success. Plast Reconstr Surg. 1996 Sep;98(3):459-63. doi: 10.1097/00006534-199609000-00015.

  PMID: 8700982 RESULT

• Nakatsuka T, Harii K, Asato H, Takushima A, Ebihara S, Kimata Y, Yamada A, Ueda K, Ichioka S. Analytic review of 2372 free flap transfers for head and neck reconstruction following cancer resection. J Reconstr Microsurg. 2003 Aug;19(6):363-8; discussion 369. doi: 10.1055/s-2003-42630.

  PMID: 14515225 RESULT

• Novakovic D, Patel RS, Goldstein DP, Gullane PJ. Salvage of failed free flaps used in head and neck reconstruction. Head Neck Oncol. 2009 Aug 21;1:33. doi: 10.1186/1758-3284-1-33.

  PMID: 19698095 RESULT

• Zhou W, Zhang WB, Yu Y, Wang Y, Mao C, Guo CB, Yu GY, Peng X. Risk factors for free flap failure: a retrospective analysis of 881 free flaps for head and neck defect reconstruction. Int J Oral Maxillofac Surg. 2017 Aug;46(8):941-945. doi: 10.1016/j.ijom.2017.03.023. Epub 2017 Apr 14.

  PMID: 28416356 RESULT

• Cannady SB, Hatten KM, Bur AM, Brant J, Fischer JP, Newman JG, Chalian AA. Use of free tissue transfer in head and neck cancer surgery and risk of overall and serious complication(s): An American College of Surgeons-National Surgical Quality Improvement Project analysis of free tissue transfer to the head and neck. Head Neck. 2017 Apr;39(4):702-707. doi: 10.1002/hed.24669. Epub 2016 Dec 21.

  PMID: 28000297 RESULT

• Heidekrueger PI, Ninkovic M, Heine-Geldern A, Herter F, Broer PN. End-to-end versus end-to-side anastomoses in free flap reconstruction: single centre experiences. J Plast Surg Hand Surg. 2017 Oct;51(5):362-365. doi: 10.1080/2000656X.2017.1283321. Epub 2017 Feb 2.

  PMID: 28151027 RESULT

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• CARLOS E TORRES FUENTES, MD.PS

  FUNDACION UNIVERSITARIA DE CIENCIAS DE LA SALUD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: January 16, 2013
• Primary Completion: May 27, 2019
• Study Completion: December 16, 2019
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share