Key result
New protocol evaluates point-of-care viscoelastic testing and platelet monitoring to predict free flap loss.
Why the study?
Microvascular free flap loss from perfusion disorders such as thrombosis is a serious complication, and the predictive value of point-of-care coagulation devices needed controlled evaluation.
Can viscoelastic testing and platelet monitoring predict free flap loss or perfusion disorders in patients undergoing maxillofacial microvascular reconstruction?
Observational (n=100)
Can viscoelastic testing and platelet monitoring predict free flap loss or perfusion disorders in patients undergoing maxillofacial microvascular reconstruction?
This study protocol outlines a prospective observational trial to evaluate the predictive value of point-of-care viscoelastic testing for flap perfusion disorders in maxillofacial reconstructive surgery.
Should not yet change flap monitoring practice; leaves open predictive value of viscoelastic testing in maxillofacial reconstruction.
BACKGROUND: In reconstructive surgery, loss of a microvascular free flap due to perfusion disorders, especially thrombosis, is a serious complication. In recent years, viscoelastic testing (VET) has become increasingly important in point-of-care (POC) anticoagulation monitoring. This paper describes a protocol for enhanced anticoagulation monitoring during maxillofacial flap surgery. OBJECTIVE: The aim of the study will be to evaluate, in a controlled setting, the predictive value of POC devices for the type of flap perfusion disorders due to thrombosis or bleeding. VET, Platelet monitoring (PM) and standard laboratory tests (SLT) are comparatively examined. METHODS/DESIGN: This study is an investigator-initiated prospective trial in 100 patients undergoing maxillofacial surgery. Patients who undergo reconstructive surgery using microvascular-free flaps will be consecutively enrolled in the study. All patients provide blood samples for VET, PM and SLT at defined time points. The primary outcome is defined as free flap loss during the hospital stay. Statistical analyses will be performed using t-tests, including the Bonferroni adjustment for multiple comparisons. DISCUSSION: This study will help clarify whether VET can improve individualized patient care in reconstruction surgery. A better understanding of coagulation in relation to flap perfusion disorders may allow real-time adaption of antithrombotic strategies and potentially prevent flap complications.
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Schröder et al. (2022) conducted an observational in Maxillofacial surgery requiring microvascular-free flaps (n=100). Viscoelastic testing (VET) and Platelet monitoring (PM) vs. Standard laboratory tests (SLT) was evaluated on Free flap loss during the hospital stay. This protocol describes a prospective observational trial of 100 patients to evaluate the predictive value of point-of-care viscoelastic testing and platelet monitoring for free flap loss.
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