Coagulation Profile in Patients Undergoing Video Assisted Thoracoscopic Surgery (VATS) for lung cancer - a randomized, controlled trial

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2012
INTERVENTION: Trade Name: Fragmin Pharmaceutical Form: Suspension for injection INN or Proposed INN: DALTEPARIN SODIUM CAS Number: 9041‐08‐1 Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 10000‐ CONDITION: Coagulation profile in patients undergoing lung surgery due to cancer in the lung. ; MedDRA version: 14.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Body processes [G] ‐ Physiological processes [G07] PRIMARY OUTCOME: Main Objective: To gather information about lung cancer patients ability to coagulate, whether they recieve prophylactic treatment or not.; To demonstrate if patients undergoing surgery for lung cancer are hypercoaguable. Primary end point(s): Coagulability measured via thromboelastometri (ROTEM), thrombingeneration, standard caogulation analysis and thrombocyte function Secondary Objective: To evaluate the effectiveness of the instituted prophylaxis Timepoint(s) of evaluation of this end point: Pre‐operative, peri‐operative and post‐operative. SECONDARY OUTCOME: Secondary end point(s): Not applicable Timepoint(s) of evaluation of this end point: Not applicable INCLUSION CRITERIA: Enlisted for lung resection due to pulmonary neoplasm Elective surgery Willingness of randomization Above 18 years Capable of giving informed consent 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Epistemonikos ID: 8d26175c55f5ea2c633da60e53eb1e6c1b129df9
First added on: Jul 27, 2021