NCT00592306

Brief Summary

The purpose of this study is to take a population of lung transplant recipients who meet UCLA criteria for induction chemotherapy with thymoglobulin and prospectively study weather giving the first dose intraoperatively versus postoperatively makes a difference with how patients do during and after lung transplantation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

3.7 years

First QC Date

December 28, 2007

Last Update Submit

September 8, 2020

Conditions

Lung Transplant

Keywords

ATGrabbit thymoglobulinreperfusion lung injuryprimary graft dysfunctionlung transplantation

Outcome Measures

Primary Outcomes (1)

  • Primary Graft Dysfunction

    the definition for primary graft dysfunction is established and will be used to determine the grade of primary graft dysfunction at 4 time points after lung transplantation

    paO2/FiO2 ratio at post transplant, 24 hr, 48 hr, and 72 hr time points

Study Arms (2)

thymoglobulin (intraoperative)

ACTIVE COMPARATOR

we plan to blindly randomize these 25 lung transplant patients to intraoperative dosing of thymoglobulin followed by 3 additional postoperative doses (the first of these 3 postoperative doses will be placebo)

Drug: thymoglobulin (intraoperative)

thymoglobulin (postoperative dosing)

PLACEBO COMPARATOR

We plan to blindly randomize these 25 lung transplant patients to 3 postoperative doses of thymoglobulin (the intraoperative dose will be placebo)

Drug: thymoglobulin (postoperative)

Interventions

thymoglobulin (intraoperative)DRUG

All patients (Arm I and Arm II) will receive 3 doses of thymoglobulin at 1.5mg/kg IV over 6 hours; only the timing of the medication is being altered. Each arm will also receive a single placebo dose. Arm I will receive thymoglobulin intraoperatively followed by a postoperative placebo dose and two subsequent thymoglobulin doses.

Also known as: thymoglobulin
thymoglobulin (intraoperative)
thymoglobulin (postoperative)DRUG

All patients (Arm I and Arm II) will receive 3 doses of thymoglobulin at 1.5mg/kg IV over 6 hours; only the timing of the medication is being altered. Each arm will also receive a single placebo dose. Arm II will receive placebo intraoperatively followed by 3 postoperative doses of thymoglobulin.

Also known as: thymoglobulin
thymoglobulin (postoperative dosing)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On a voluntary basis, all patients eligible for bilateral lung transplantation between the ages of 18-65 years (inclusive)

You may not qualify if:

  • Have any known allergy to horse or rabbit antithymocyte polyclonal agents
  • Have a preoperative platelet count less then 100,000/mm3
  • Are recipients of multiple organ transplants (either simultaneous or sequential)
  • Are recipients of a single lung transplantation
  • Have a contraindication to rabbit antithymocyte globulin based on judgement of the investigators (i.e. bleeding diathesis or overwhelming risk of intense immunosuppression) including the following patients: greater than 65 years of age, prior diagnosis of malignancy (with the exception skin malignancies), underlying suppurative lung disease (i.e. bronchiectasis, cystic fibrosis, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA

Los Angeles, California, 90095-1690, United States

Location

MeSH Terms

Conditions

Primary Graft Dysfunction

Interventions

thymoglobulinPostoperative Period

Condition Hierarchy (Ancestors)

Reperfusion InjuryVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative PeriodSurgical Procedures, OperativePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rajan Saggar, MD

    Pulmonology & Critical Care at UCLA

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 14, 2008

Study Start

January 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

US(1)