Study design overview, surgical strategy and outcomes
blood loss, bleeding, coagulopathy, Coagulopathy
BLEEDING, LUNG, CLOT, COAGULOPATHY, BLOOD LOSS, LYSIS, SECONDARY, COAGULOPATHY, HEART
A secondary analysis of the Point of Care Management of Coagulopathy in Lung Transplantation trial (NCT03598907) was performed. This study was a single-site, prospective randomized controlled trial that examined the utilization of perioperative POC-targeted coagulopathy management in conjunction with 5% albumin solution and their effect on perioperative blood loss and consumption of blood products during LuTx. This study was approved by the institutional ethics committee (reference number EK-1402/17) and was registered in the clinical trial database at ClinicalTrials.gov (identifier number NCT03598907) prior to patient enrollment. All patients provided written informed consent for participation in the study before the LuTx procedure.As this was a pilot study, the projected number of patients to be recruited was estimated at 120 (planned for 4 years), and an a priori power analysis was not performed in this case. An interim analysis was planned after evaluation of approximately 60 patients (after 2 years). Patients were primarily randomized to two study groups – POC group and non-POC group. The perioperative anesthesia management strategy used for both the non-POC group and POC group has been described previously [Intravascular volume in this group was replaced with balanced crystalloid, non-albumin colloidal solutions such as 6% hydroxyethyl starch or 4% succinylated gelatin, and FFP. Median volume of balanced crystalloid solution and non-albumin colloidal solutions was 1000 ml (IQR 512.5; 987.5 – 1500) and 775 ml (IQR 500; 500 – 1000), respectively. Triggers to volume replacement in both POC and non-POC groups included circulatory stability expressed by dose of norepinephrine (µg/kg/min) and transesophageal echocardiography (TEE) assessment of decreased cardiac preload by left ventricular fractional area change in transgastric mid-papillary short axis view at 50% calculated veno-arterial extracorporeal membrane oxygenation (VA ECMO) flow. However, due to the limitations described of TEE as a sole intraoperative monitor of systemic volume during VA ECMO, monitors aiding in the assessment of ongoing resuscitation also included urine output and maintenance of pulsatility within systemic and pulmonary arterial waveforms [In the POC group, perioperative bleeding and coagulopathy were managed according to the POC methods performed at the beginning of the surgery, after reperfusion of the first implanted lung and at the end of the surgical procedure (Fig. ROTEM protocol for the diagnosis of coagulopathy and goal-directed therapy using EXTEM, FIBTEM, and APTEM. Abbreviations: A10: Amplitude at 10 min; CT: clotting time; IU: international unit; LI30, LI60: lysis index at 30 and 60 min, MCF: maximum clot firmness; ML: maximum lysis. Previously published in Durila M, Vajter J, Garaj M, Pollert L, Berousek J, Vachtenheim J, Jr., et al. Rotational thromboelastometry reduces blood loss and blood product usage after lung transplantation. J Heart Lung Transplant. 2021;40(7):631–41.Primary outcome for this secondary analysis was PGD development and grading during the first 72 h after lung transplantation. Measures of Horowitz index (P/F ratio; defined as arterial oxygen pressure (P