Clinical Trials Logo
  1. Home
  2. Intraoperative Complications
  3. NCT00293514
  4. Details
NCT00293514 Clinical Trial

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

Intraoperative Complications Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00293514
Other study ID # TC-021-IM
Secondary ID 2004-002380-24
Status Completed
Phase Phase 3
First received February 15, 2006
Last updated May 4, 2012
Start date February 2006
Est. completion date October 2007

Study information
Verified date February 2008
Source Nycomed
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and WomenBelgium: Ministry of Social Affairs, Public Health and the EnvironmentDenmark: Danish Medicines AgencyGermany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyItaly: Ministry of HealthSweden: Medical Products AgencySwitzerland: Swissmedic
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fibrinogen (human) + thrombin (human) (TachoSil)

Locations
Country Name City State
Denmark Nycomed Roskilde

Sponsors (1)
Lead Sponsor Collaborator
Nycomed

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Reduction of intra-operative air leakage intensity after first application of trial treatment
See also
  Status Clinical Trial Phase
Completed NCT04519203 - The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery N/A
Completed NCT02296619 - The Effects of Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy Phase 4
Completed NCT02043132 - Tranexamic Acid in Reverse Total Shoulder Arthroplasty Phase 2/Phase 3
Withdrawn NCT00861367 - Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate N/A
Completed NCT04517461 - Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery
Completed NCT02419053 - Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children N/A
Terminated NCT00308100 - Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation Phase 4
Active, not recruiting NCT04443465 - Patient Experiences of IONM and Outcomes
Recruiting NCT06426381 - The Effect of Therapeutic Touch Applied During Knee Replacement Surgery on Anxiety, Vital Signs and Comfort Level N/A
Completed NCT05550181 - Intraoperative Hypocapnia in PROVHILO and PROBESE
Completed NCT01664806 - Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin Phase 3
Completed NCT00683293 - Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy N/A
Terminated NCT00364494 - Hemodilution and Outcome in Cardiac Surgery N/A
Completed NCT05136157 - Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control Early Phase 1
Terminated NCT03665259 - Lower Inspiratory Oxygen Fraction for Preoxygenation N/A
Completed NCT02773199 - Effects of Preoperative Fasting on ECG and Vital Parameters N/A
Completed NCT03974321 - Intraoperative Hypotension and Perioperative Myocardial Injury
Completed NCT00197353 - Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block Phase 3
Enrolling by invitation NCT05270603 - The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)
Completed NCT03467230 - Performance Assessment of the PMD-200 Under General Anesthesia