NCT00293514

Brief Summary

The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2006

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

February 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 7, 2012

Status Verified

February 1, 2008

Enrollment Period

1.7 years

First QC Date

February 15, 2006

Last Update Submit

May 4, 2012

Conditions

Pulmonary DiseasesIntraoperative Complications

Keywords

standard surgical treatment for air leakage in pulmonary lobectomy

Outcome Measures

Primary Outcomes (1)

  • Duration of post-operative air leakage: assessment on the evening of the day of operation (Day 0) and then subsequently twice daily (on morning and evening shifts)

Secondary Outcomes (1)

  • Reduction of intra-operative air leakage intensity after first application of trial treatment

Interventions

Fibrinogen (human) + thrombin (human) (TachoSil)DRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nycomed

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Lung DiseasesIntraoperative Complications

Interventions

FibrinogenThrombinTachoSil

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological FactorsSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine Proteases

Study Officials

  • Nycomed Clinical Trial Operations

    Headquarters

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 17, 2006

Study Start

February 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 7, 2012

Record last verified: 2008-02

Locations

DK(1)