NCT00506532

Brief Summary

  1. 1.Working Hypothesis:
  2. 2.Aims of the Study:

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 25, 2007

Status Verified

July 1, 2007

First QC Date

July 15, 2007

Last Update Submit

July 23, 2007

Conditions

Lung TransplantationPrimary Graft Dysfunction

Keywords

Pulmonary SurfactantsLung transplantationPrimary Graft Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Effect of intraoperative exogenous surfactant treatment on oxygenation and primary graft dysfunction (PGD) prevention (primary outcome)

    3 days post operation

Secondary Outcomes (1)

  • Recovery-Extubation ;Seating time; Icu stay; Hospital stay; Lung function

    1 month

Interventions

Surfactant (calfactant)DRUG

Eligibility Criteria

Age16 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Candidates for lung transplantation

You may not qualify if:

  • Differential diagnosis of PGD
  • Pulmonary Edema
  • Stenosis or thrombosis of pulmonary artery/vein anastomosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Institute Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

MeSH Terms

Conditions

Primary Graft Dysfunction

Interventions

Surface-Active Agentscalfactant

Condition Hierarchy (Ancestors)

Reperfusion InjuryVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • MordechaI R Kramer, Prof

    Pulmonary Institute Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mordechai R Kramer, Prof

CONTACT

972-3-9377121kremerm@clalit.org.il

Anat Amital, Dr

CONTACT

972-3-9377140anatam@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2007

First Posted

July 25, 2007

Study Start

January 1, 2005

Study Completion

December 1, 2008

Last Updated

July 25, 2007

Record last verified: 2007-07

Locations

IL(1)