NCT01528267

Brief Summary

The prupose of this study is to determine the feasibility, effectiveness, and safety of injecting blood into the airways to cause lung volume reduction in people with severe emphysema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

3.3 years

First QC Date

February 3, 2012

Last Update Submit

December 19, 2013

Conditions

Emphysema

Keywords

Emphysema, lung volume reduction, autologous blood

Outcome Measures

Primary Outcomes (1)

  • Evidence of scarring and volume loss on CT scanning

    6 weeks

Secondary Outcomes (1)

  • To ensure no significant lung function deteriorations at 6 weeks post-procedure

    6 weeks

Study Arms (2)

Autologous blood

ACTIVE COMPARATOR

Patients will have 50mls of autologous blood injected into each of 3 bronchopulmonary segments during bronchoscopy under conscious sedation.

Other: Autologous blood

Saline

SHAM COMPARATOR

Patients will have 50mls of normal saline injected into each of 3 bronchopulmonary segments during bronchoscopy under conscious sedation.

Other: Normal saline

Interventions

Autologous bloodOTHER

50mls of autologous blood injected into each of 3 bronchopulmonary segments.

Autologous blood
Normal salineOTHER

50mls of normal saline injected into each of 3 bronchopulmonary segments.

Saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 years
  • Moderate to severe airflow obstruction FEV1 \<50% Predicted
  • Severe dyspnoea - mMRC ≥2
  • Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
  • Optimum COPD treatment for at least 6 weeks
  • No COPD exacerbation for at least 6 weeks
  • Less than 3 admissions for exacerbation in the preceding 12 months

You may not qualify if:

  • Patient unable to provide informed consent
  • Total lung CO uptake (TLCO) \<15% predicted and FEV1 \<15% predicted
  • pO2 on air \<6.0kPa
  • pCO2 on air \>8.0kPa
  • Other major medical illness, e.g. lung cancer that will limit participation
  • Clinically significant bronchiectasis
  • Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
  • Arrhythmia or cardiovascular disease that poses a risk during procedure
  • Prednisolone dose greater than 10mg a day
  • Prior LVRS or lobectomy
  • Lung nodule requiring surgery
  • Female of childbearing age with positive pregnancy test
  • Subject participated in a research study of investigational drug or device in prior 30 days
  • Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

  • Kobayashi H, Kanoh S. [Bronchoscopic autologous blood injection for lung volume reduction]. Nihon Kokyuki Gakkai Zasshi. 2009 Sep;47(9):765-71. Japanese.

    PMID: 19827579BACKGROUND

MeSH Terms

Conditions

Emphysema

Interventions

Blood Transfusion, AutologousSaline Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Pallav Shah, MBBS, MD

    Chelsea and Westminster NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 7, 2012

Study Start

November 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations

GB(1)