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Trial record 1 of 1 for:    NCT01741506
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Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer (COPPVATS)

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ClinicalTrials.gov Identifier: NCT01741506
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas Decker Christensen, Aarhus University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Dalteparin (Fragmin®) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer - A Randomized, Controlled Trial
Study Start Date : March 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Dalteparin (Fragmin®)
Dalteparin (Fragmin®) 5000 IU (International Unit) once daily
Drug: Dalteparin (Fragmin®)
No Intervention: No treatment
No treatment
Open surgery arm
Dalteparin (Fragmin®) 5000 IU once daily
Drug: Dalteparin (Fragmin®)



Primary Outcome Measures :
  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 Outcome Measures :
  1. 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].


Other Outcome Measures:
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741506


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark, 8200
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Thomas Decker Christensen
Investigators
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Principal Investigator: Thomas D Christensen, MD Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Decker Christensen, Senior staff surgeon, MD, DMSc, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01741506     History of Changes
Other Study ID Numbers: COPPVATS vs 1.1
2012-002409-23 ( EudraCT Number )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: April 2015
Keywords provided by Thomas Decker Christensen, Aarhus University Hospital:
Lung cancer
Surgery
Thromboembolism
Bleeding
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action