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

Vascular Thrombosis Clinical Trial

— RBCT  

Official title:

Red Blood Cell Transfusion and Its Association With Vascular Pedicle Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04860544
• Other study ID #: 462-3762-17
• Status: Completed
• Start date: January 16, 2013
• Est. completion date: December 16, 2019

Study information

• Verified date: May 2021
• Source: Fundación Universitaria de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: December 16, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thrombosis
• Vascular Thrombosis

Intervention

Procedure:
• RED BLOOD CELLS TRANFUSION

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Universitaria de Ciencias de la Salud	Hospital de San Jose

References & Publications (7)

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 P — View Citation

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 20 — View Citation

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. — View Citation

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. — View Citation

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 3 — View Citation

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. Review. — View Citation

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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	arterial or venous non-thrombotic vascular complications in the flap	As 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	7 DAYS