NIH GUIDE, Volume 25, Number 17, May 24, 1996




P.T. 34


  Clinical Trial 

  Pulmonary Diseases 

  Data Management/Analysis+ 


National Heart, Lung, and Blood Institute


The National Heart, Lung and Blood Institute (NHLBI) of the National

Institutes of Health (NIH) and the Health Care Financing

Administration will jointly sponsor and support a seven year

multi-center randomized, clinical trial in association with a

prospective registry to examine the role of Lung Volume Reduction

Surgery (LVRS) in the treatment of end-stage emphysema, evaluate the

long term outcome of LVRS on function, morbidity and mortality and

define appropriate patient selection criteria for the procedure.  The

program will consist of approximately 10 to 15 clinical centers and a

clinical coordinating center (CCC).  The clinical centers will be

awarded under a separate RFP NHLBI-HR-97-02.  A registry will be

established to serve as a repository of severe end stage

emphysematous patients, who have been referred for evaluation for

LVRS, transplant or pulmonary rehabilitation to any of the

participating clinical centers.  Patients in the registry meeting

selection criteria will be invited for inclusion in the randomized

study.  Patients, who are not randomized, but agree to be in the

registry will be followed twice yearly.  Patients meeting eligibility

requirements will be randomized to receive either maximal medical

therapy or maximal medical therapy with LVRS.  LVRS will be performed

by median sternotomy or by bilateral video-assisted thorascopic

surgery (VATS) with excision of 20 to 30 of each lung.  Centers will

apply to randomize to either (a) medical therapy versus medical

therapy with LVRS by median sternotomy, (b) medical therapy versus

medical therapy with LVRS by bilateral VATS or (c) medical therapy

versus medical therapy with LVRS by median sternotomy versus medical

therapy with LVRS by bilateral VATS.  Maximum medical therapy will

include pulmonary rehabilitation and education.  End-points will

include exercise ability, pulmonary function, quality of life,

morbidity and mortality.  The study population will consist of 200

patients recruited into each arm of the three arm trial comparing

surgery A versus surgery B versus medical therapy.  An additional 495

patients will be recruited into each of two arms among clinical

centers performing only one kind of surgery and medical treatment.

This will require a total of 2580 participants in the three armed and

two arm trials combined for the randomized, clinical trial.  The

study will be conducted in three phases.  Phase I (9 Months) will be

for development of a protocol and manual of operations and

recruitment and training of personnel.  During this phase the CCC

staff will collaborate fully with the clinical center principal

investigators in the development of the study protocol and the manual

of operations and provide statistical and organizational expertise.

Phase II (63 Months) will be for recruitment of patients,

randomization and follow-up of subjects.  During this phase the CCC

will receive, collect, process, store, and analyze data collected

from the participating clinical centers.  The CCC will assure

compliance of the clinical centers with patient entry and

randomization criteria, recruitment schedules, pulmonary

rehabilitation, medical and surgical study protocols and other

guidelines in the manual of operations.  The CCC will conduct site

visits, assure that data are forwarded in accordance with an

established time schedule, review data for accuracy and completeness,

assure that quality control is maintained during the collection and

processing of data.  The CCC will prepare and distribute periodic

technical and statistical reports to the participating clinical

centers, the project officer, a HCFA representative and the

contracting officer.  Phase III (12 Months) will be for analysis of

data and writing of manuscripts describing results of the study.

During phase III, the CCC will collaborate with the study

investigators and the project officer to conduct the final analyses

of the data and to write manuscripts describing results of the study.

Throughout the study, the CCC will coordinate, manage and participate

in meetings of the Steering Committee with direction from NHLBI,

produce and distribute minutes of these meetings; assist the Project

Officer in preparing the agendas for periodic meetings of the Data

Safety Monitoring Board and make presentations at the Policy Board

meetings.  The CCC must have experience with complex multi-center

trials and registries, readily available medical expertise relevant

to emphysema, pulmonary medicine and thoracic surgery and the ability

to analyze a large volume of physiologic, surgical and medical

morbidity and mortality data.  The CCC will frequently need to make

quick decisions, often based on medical information obtained from the

clinics.  Therefore, staff will need to possess the strong medical

and scientific qualifications and experience relating to Chronic

Obstructive Pulmonary Disease (COPD) and LVRS to interact effectively

as peers with the multiple medical disciplines (surgery, pulmonary,

rehabilitation, radiology, anesthesiology, and physiology)

represented in this program.




This is not an RFP.  RFP NHLBI-HR-97-01 will be available on or about

June 3, 1996, with proposals due on or about August 5, 1996.  Award

of a contract for this study will be made only to offerors located in

the United States of America.  The RFP will be available on the NIH

Gopher.  Access via the NIH Website (  At the NIH

Home Page select "Grants & Contracts" then select "R&D Requests for

Proposals (RFP)".  Offerors that have access to the NIH Gopher Server

can access the RFP by pointing your gopher client to GOPHER.NIH.GOV/.

Select "Grant and Research Information", then select "R&D Request for

Proposals (RFP)".  The RFP may also be obtained by writing to:


Joanne C. Deschler

HLVD Contracts Section

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, MSC 7902

Bethesda, MD  20892



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