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Effects of autologous (OWN) platelet-poor plasma on prevention of bronchopleural fistula and lung damage in patients undergoing lung resection

CLINICAL ASSESSMENT OF THE EFFECTS OF AUTOLOGOUS PLATELET-POOR PLASMA ON PREVENTION OF BRONCHOPLEURAL FISTULA AND LUNG DAMAGE IN PATIENTS UNDERGOING LUNG RESECTION SURGERY - PLASMAFIST-2011

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000397-30-ES
Enrollment
Unknown
Registered
2012-10-15
Start date
2013-02-07
Completion date
Unknown
Last updated
2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopleural fistula MedDRA version: 14.1 Level: PT Classification code 10053481 Term: Bronchopleural fistula System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Autologous platelet-poor plasma Pharmaceutical Form: Gel INN or Proposed INN: platelet-poor plasma Other descriptive name: platelet-poor plasma Concentration unit: ml millilitre(s) Conce

Sponsors

FUNDACIÓN CANARIA DE INVESTIGACIÓN Y SALUD (FUNCIS)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients over 30 y/o Tumor-free margins in the surgical specimen -Patients who underwent pneumonectomy, lobectomy, or bilobectomy for lung cancer Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: -There is no upper age limit -Infections prior to surgery (pleural empyema) -Tumor-affected surgical margins

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficiency of autologous platelet-poor plasma (PPP) in the prevention of bronchopleural fistula in patients undergoing lung resection.;Secondary Objective: -To reduce the incidence of bronchopleural fistula in patients undergoing pneumonectomy. -To reduce the incidence of bronchopleural fistula in patients undergoing lobectomy. -Reduction of morbidity and mortality of patients undergoing lung resection surgery - To measure the extent of heling and remodeling of the bronchial stump after local application of PPP. -To decrease the economic cost of patients undergoing lung resection surgery;Primary end point(s): - 22% reduction in the presence of FBP in patients with pneumonectomy and treatment with PPP. - 7.5% decrease in the presence of FBP in patients with lobectomy / bilobectomy and treatment with PPP. - Reduction of morbidity and mortality in patients undergoing lung resection.;Timepoint(s) of evaluation of this end point: At the end of the follow-up (month 6)—

Secondary

MeasureTime frame
Secondary end point(s): - Increased capacity of healing and remodeling of the bronchial stump after local application of PPP. -Decrease the economic cost of patients undergoing lung resection;Timepoint(s) of evaluation of this end point: At the end of the follow-up (month 6)—

Countries

Spain

Contacts

Public ContactDr. Norberto Santana

Unidad de Investigación. Hosp Univ de GC Dr. Negrín

norbesr@terra.es+34928449272

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026