Primary Graft Dysfunction Score in Lung Transplantation | NCT03276403

Studies
Primary Graft Dysfunction Score in Lung Transplantation

NCT03276403

Sponsor

Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD

Status

Unknown status

Last Update Posted

Sep 8, 2017Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Lung Transplant; Complications

Interventions

PiCCO Catheter

Countries

Austria
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2016Actual

Primary Completion Date

Dec 1, 2017Estimated

Completion Date

Mar 1, 2018Estimated

First Submitted Date

Sep 6, 2017

First Submission Date that Met QC Criteria

Sep 6, 2017

First Posted Date

Sep 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2017

Last Update Posted Date

Sep 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD, Assoc.-Prof. Dr. Konraf Hoetzenecker, PhD, Medical University of ViennaSponsor-Investigator

Lead Sponsor

Assoc.-Prof. Dr. Konrad Hoetzenecker, PhDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The validity of several functional parameters, which could be included in a new PGD scoring system, will be tested in a prospective pilot study of 80 consecutive bilateral lung transplant recipients in high volume lung transplant centers. Functional parameters will be collected at different time points within the first 72hrs after lung transplantation and their accuracy in predicting clinical outcome as well as their correlation with lung water content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a novel PGD score), which can then be tested in future prospective trials.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PiCCO Catheter	Device	The PiCCO Catheter is an investigational device intended to measure lung water content in individuals requiring advanced haemodynamic monitoring. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.

Measure	Description	Time Frame
Primary graft dysfunction		72 hours after transplantation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Double lung transplantation for primary pulmonary hypertension (PPH), Fibrosis, cystic fibrosis (CF), Emphysema
No restrictions regarding donor lungs (marginal donors, EVLP possible)
No restrictions regarding size reduction (anatomic wedge resections, three lobar, lobar transplantations)

Exclusion Criteria:

Single-lung transplantation
Heart-lung transplantation
Re-transplantation
Patients with bridge-to-transplantation with a mechanical assist device (extra-corporal membrane oxygenation (v/v, v/a), PA/LA Novalung, ILAactive, ILA)
Clinical situations leading to inaccurate PiCCO measurements e.g. intracardiac shunts, significant tricuspid regurgitation, cooling
No access to the femoral artery possible
Severe postoperative hemorrhage, which leads to hematothorax and makes revision surgery necessary

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients receiving double lung transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Konrad Hoetzenecker, MD, PhD	Contact	0043140400	56990	konrad.hoetzenecker@meduniwien.ac.at
Thomas Schweiger, MD, PhD	Contact	0043140400	56990	thomas.schweiger@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Konrad Hoetzenecker, MD, PhD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD will be shared upon request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided