EUCTR2017-003931-12-IT
Active, not recruiting
Phase 1
A Randomized Controlled Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or ReducingPostoperative Air Leaks After Pulmonary Resection - NA
BAXTER HEALTHCARE CORPORATION, ONE BAXTER PARKWAY, DEERFIELD, ILLINOIS 60015, USA0 sites169 target enrollmentJune 20, 2019
ConditionsPostoperative air leakage.MedDRA version: 20.0Level: PTClassification code 10066239Term: Mediastinal shiftSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Postoperative air leakage.
- Sponsor
- BAXTER HEALTHCARE CORPORATION, ONE BAXTER PARKWAY, DEERFIELD, ILLINOIS 60015, USA
- Enrollment
- 169
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preoperative criteria
- •Patients, 18 years or older at the time of signing the informed consent form (ICF), undergoing elective pulmonary resections (lobectomy,
- •segmentectomy, or wedge resection), either through open thoracotomy or through Video\-Assisted Thoracoscopic surgery (VATS).
- •Patients or legally authorized representatives, who are able to give IC after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period.
- •If female of child\-bearing potential, patient will present with a negative blood/urine pregnancy test, and will agree to employ adequate birth control measures for the duration of the study.
- •Intraoperative criteria
- •Patients with grade 1 or 2 (Macchiarini scale) air leakage after primary stapling and limited suturing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Preoperative criteria
- •Patients who had previous lung surgery (on the same side)
- •Patients with an active, florid infection
- •Patients who have received chemotherapy within the previous 3 weeks.
- •Patients who have received radiation therapy within the previous 4 weeks.
- •Patients with known hypersensitivity to the components of the investigational product and control (human fibrinogen, human thrombin,
- •collagen of any origin, NHS\-PEG)
- •Patients undergoing emergency surgery
- •Patients on chronic use of steroids
- •Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
Outcomes
Primary Outcomes
Not specified
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