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Completed

NCT Number: NCT01741506

Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer

The purpose of the study is:

To estimate patients with lung cancers who will undergo surgery total haemostatic / thrombotic capacity pre, per-and postoperatively.

To investigate whether prophylactic treatment with Low Molecular Weight Heparin (LMWH) affects the patient's potential hypercoagulability.

To investigate whether there are differences in patients who will undergo Video Assisted Thorascopic Surgery (VATS) or open surgery in regards of impact of the coagulation system.

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Key information

Conditions

Lung Cancer Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dalteparin (Fragmin®)

Drug

Primary outcomes

  1. Thromboelastometry (ROTEM®)

    Time frame: 30 days

    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)

Secondary outcomes

  1. Thrombin generation

    Time frame: 30 days

    • recalcificering, 2) activation with tissue factor 1:17,000 and estimation of Lag time [min], ETP (endogenous thrombin potential) [nM (nanomole) thrombin*minute], peak levels of thrombin generation [nM thrombin] and time to peak thrombin (ttpeak) [min].

Other outcomes

  1. Standard coagulation analysis

    Time frame: 30 days

    APTT (activated partial thromboplastin time), INR (International Normalized Ratio), fibrinogen, fibrin d-dimer, thrombin time, thrombocytes and Factor VIII: clot.

  2. Thrombocyte function analysis

    Time frame: 30 days

    analysis on Multiplate®, where the thrombocyte aggregation are expressed as Aggregation unit (AU), area under curve (A*min).

Sponsors and collaborators

Lead sponsor

Thomas Decker Christensen

Other

Registry information

Official study title

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

Acronym: COPPVATS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2012
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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