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

Overview

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.

Full Title of Study: “Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer – A Randomized, Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2015

Detailed Description

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.

Interventions

  • Drug: Dalteparin (Fragmin®)

Arms, Groups and Cohorts

  • Experimental: Dalteparin (Fragmin®)
    • Dalteparin (Fragmin®) 5000 IU (International Unit) once daily
  • No Intervention: No treatment
    • No treatment
  • Other: Open surgery arm
    • Dalteparin (Fragmin®) 5000 IU once daily

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Thrombin generation
    • Time Frame: 30 days
    • 1) 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].

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Thomas Decker Christensen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Thomas Decker Christensen, Senior staff surgeon, MD, DMSc, PhD – Aarhus University Hospital
  • Overall Official(s)
    • Thomas D Christensen, MD, Principal Investigator, Aarhus University Hospital

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