View clinical trials related to Primary Graft Dysfunction.
Filter by:Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.
Pulmonary transplantation is a very demanding surgical procedure, often accompanied by coagulopathy and severe perioperative bleeding. The most common complication that develops within the first 72 hours after surgery is primary graft dysfunction (PGD), up to 30% in the most severe form. The etiology of PGD is multifactorial. One of the causes may be the amount of perioperative blood loss. Intravascular volume is normally maintained by the administration of crystalloid and colloid solutions and fresh frozen plasma, which is also used to treat coagulopathy, however it is administered at the discretion of the anaesthetist and his experience, practically meaning ,,blindly". In the field of the allogeneous ischemic organ, these substitution solutions essentially become another allogeneous material and can cause undesired immunomodulation and contribute to the development of PGD. In our prospective randomized trial (120 patients), two patient groups will be investigated. In the first group, the coagulopathy and perioperative blood loss will be treated by the current standard approach, by ,,blind" administration of fresh frozen plasma, crystalloids and colloids. In the second group, the cause of coagulopathy will be diagnosed and treated according to the point-of-care (POC) results of ROTEM, PFA 200 and Multiplate. A colloidal solution of 5% albumin will be used to replace the circulating volume and maintain the oncotic pressure. Investigators assume that the POC management of coagulopathy and bleeding in the second group will lead to a reduction in perioperative bleeding, to reduced administration of infusion solutions, and thus to a reduction of the incidence of PGD.
This is a Phase 2 observational nonrandomized pilot investigation to evaluate the safety and efficacy of Sodium Nitrite administration for the reduction of Primary Graft Dysfunction (PGD) in patients undergoing lung transplant. The study will enroll 8 subjects, undergoing lung transplant at the University of Pittsburgh Medical Center (UPMC).