Coagulation Profile in Patients undergoing Surgery for Lung Cancer

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002409-23-DK

Enrollment

Registered

2012-07-13

Start date

2012-09-21

Completion date

Unknown

Last updated

2020-11-09

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

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Thromboembolic events during the last 3 months (both venous and arterial) Pregnancy Breastfeeding Anti-koagulant therapy with an vitamin K-antagonist or direct og in-direct thrombin-inhibitor Not sufficient pausing of thrombocyte-inhibitors Allergies towards LMWH

Design outcomes

Primary

Measure	Time frame
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.;Secondary Objective: To evaluate the effectiveness of the instituted prophylaxis;Primary end point(s): Coagulability measured via thromboelastometri (ROTEM), thrombingeneration, standard caogulation analysis and thrombocyte function;Timepoint(s) of evaluation of this end point: Pre-operative, peri-operative and post-operative.	—

Measure

Time frame

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.;Secondary Objective: To evaluate the effectiveness of the instituted prophylaxis;Primary end point(s): Coagulability measured via thromboelastometri (ROTEM), thrombingeneration, standard caogulation analysis and thrombocyte function;Timepoint(s) of evaluation of this end point: Pre-operative, peri-operative and post-operative.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactHeart-, Lung-, Vascular Department

Aarhus University Hospital

s.pedersen@yahoo.dk

Outcome results

None listed

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