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Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer - A Randomized, Controlled Trial


Phase 4
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer - A Randomized, Controlled Trial


Lung cancer is a serious and very frequent disease. For those 25% of the patients who will
undergo surgery, there are two different methods of operation: either open surgery
(thoracotomy) or Video Assisted Thorascopic Surgery (VATS). The latter method is increasing
in use.

Patients are often prescribed heparin pre- postoperatively, but it is unclear whether this
prophylactic treatment is necessary, and it has never been thoroughly investigated.

When patients receive heparin there is an increased risk of bleeding.

Furthermore, it is unclear what changes occurs in the coagulation system pre, per- and
postoperatively in patients undergoing surgery for lung-cancer, and hereby it is unclear
whether these patients should have some sort of medical prophylactic treatment.

By using new analysis methods in terms of Thromboelastometry, Thrombin generation and
thrombocyte function analysis, hereby the total coagulation profile can be characterized and
hereby estimate the risk of thrombosis and bleeding. Thereby better be able to give the
right treatment for these patients.


Inclusion Criteria:



- Undergo surgery for lung cancer with an expected lobectomy or bilobectomy

- The surgery shall be VATS (for patients in the group randomized to other low
molecular weight heparin and no prophylactic)

- Willing to be randomized (VATS-patients)

- Over 18 years old.

- Able to give assigned informed consent

- Women should be prescribed secure anticonception.

Exclusion Criteria:

- Thromboembolic events within the last three months (both venous and arterial)

- Pregnant

- Lactating

- Treatment with anticoagulation therapy in terms of vitamin K antagonist or direct or
indirect thrombin inhibitors (dabigatran, apixaban or rivaroxaban)

- Treatment with thrombocyte function inhibitors in terms of Clopidogrel, ASA
(acetylsalicylic acid), prasugrel and ticagrelor, and no pause of minimum 5 days (7
days with regards of prasugrel) before surgery

- Allergy for LMWH

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Thromboelastometry (ROTEM®)

Outcome Description:

Analysis of in-tem, ex-tem, fib-tem og hep-tem and estimation of: Clotting time (CT (sec)), propagation (MaxVel (mm*100/sec) t,MaxVel, s) og termination (maximum clot firmness (MCF)(mm*100/sec)

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Thomas D Christensen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aarhus University Hospital

Authority:

Denmark: Ethics Committee

Study ID:

COPPVATS vs 1.1

NCT ID:

NCT01741506

Start Date:

January 2013

Completion Date:

September 2014

Related Keywords:

  • Lung Cancer
  • Lung cancer
  • Surgery
  • Thromboembolism
  • Bleeding
  • Lung Neoplasms

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