 Overall there have been few randomized controlled studies that have examined the efficacy or effectiveness of FP transfusions. Only 3 randomized controlled studies evaluating the effectiveness of FP as compared to no treatment prior to invasive procedures have been carried out. All 3 studies failed to recruit sufficient patients due to important issues in the design of these trials. The main failure in the first two studies was the narrow eligibility criteria. Two studies only included patients undergoing a single type of procedure and they included only patients with very mild coagulation abnormalities i.e. an INR equivalent of less than 2.0. Thus, many patients with modest coagulation abnormalities were excluded thereby leaving only a small pool of potentially eligible patients. The third study failed to recruit patients for a number of reasons including restrictive inclusion criteria and inability to obtain consent for emergency procedures especially after hours. While this study recruited patients undergoing a variety of invasive procedures and used a wider INR threshold, they did reduce the number of potentially eligible patients by not including patients with thrombocytopenia or patients on anti-platelet agents both common in ICU patients. Less than 30 of eligible patients were enrolled as informed consent from the patients or a surrogate was required prior to enrolling the patient. As ICU patients frequently have prolonged INR tests and require urgent procedures at the time of admission, a deferred consent process and the ability to enroll patients after hours is absolutely essential to ensure that eligible ICU patient who are usually not able to give consent are not systematically excluded from the trial due to the need for informed consent. 