Planned Semi-Elective Lung Tx Study

University of Florida45 enrolled

Overview

When suitable donor lungs become available for a consented recipient, and the donor cross clamp time occurs between 6pm and 4am, the transplant procedure (anesthesia starting time) will be allowed to be moved to a 6am start or later with the lungs being preserved at 10C cold static preservation upon organ arrival to our hospital using a specific refrigerator. The maximum allowed time between donor cross clamp and recipient anesthesia initiation will be 12h.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

To Compare Lung Transplant Outcomes Between Study Patients and Standard Patients Who Have Already Undergone Lung Transplantation by Conventional Procedures Lung Transplant

Interventions

Experimental: Preserving of Donor LungsPROCEDURE

lung transplants that have a proposed after hours start time will be delayed until 6am and the donor lungs will be preserved for no more than 12 hours at 10 degrees celsius cold static

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary lung transplantation * Informed consent provided Donor Inclusion: Age\<70 Exclusion Criteria: * Re-transplantation * Multi-organ transplantation Donor exclusion criteria: * Age \>70y * Concerns with organ preservation technique

Locations (1)

UFHealth Shands

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (expected rate less than 20%)

Time frame: 72 hours post op

Secondary Outcomes

1-year survival

Time frame: procedure up to 1 year post op

Data from ClinicalTrials.gov

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