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OpenTrials
Completed

NCT Number: NCT00293514

TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)

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.

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Key information

Conditions

Pulmonary Diseases Intraoperative Complications Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nycomed

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

Drug

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

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study title

An Open, Randomised, Prospective, Multi-centre, Parallel-group Trial of TachoSil Versus Standard Surgical Treatment in Patients Undergoing Pulmonary Lobectomy for Lung Malignancy and Requiring Treatment for Air Leakage

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 17, 2006
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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