Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer (COPPVATS)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dalteparin (Fragmin®)
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, Surgery, Thromboembolism, Bleeding
Eligibility 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
Sites / Locations
- Aarhus University Hospital
- Rigshospitalet
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Other
Arm Label
Dalteparin (Fragmin®)
No treatment
Open surgery arm
Arm Description
Dalteparin (Fragmin®) 5000 IU (International Unit) once daily
No treatment
Dalteparin (Fragmin®) 5000 IU once daily
Outcomes
Primary Outcome Measures
Thromboelastometry (ROTEM®)
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
Thrombin generation
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].
Full Information
NCT ID
NCT01741506
First Posted
November 25, 2012
Last Updated
June 22, 2015
Sponsor
Thomas Decker Christensen
1. Study Identification
Unique Protocol Identification Number
NCT01741506
Brief Title
Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer
Acronym
COPPVATS
Official Title
Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer - A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Decker Christensen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, Surgery, Thromboembolism, Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dalteparin (Fragmin®)
Arm Type
Experimental
Arm Description
Dalteparin (Fragmin®) 5000 IU (International Unit) once daily
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment
Arm Title
Open surgery arm
Arm Type
Other
Arm Description
Dalteparin (Fragmin®) 5000 IU once daily
Intervention Type
Drug
Intervention Name(s)
Dalteparin (Fragmin®)
Primary Outcome Measure Information:
Title
Thromboelastometry (ROTEM®)
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)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Thrombin generation
Description
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].
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Standard coagulation analysis
Description
APTT (activated partial thromboplastin time), INR (International Normalized Ratio), fibrinogen, fibrin d-dimer, thrombin time, thrombocytes and Factor VIII: clot.
Time Frame
30 days
Title
Thrombocyte function analysis
Description
analysis on Multiplate®, where the thrombocyte aggregation are expressed as Aggregation unit (AU), area under curve (A*min).
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas D Christensen, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
29270080
Citation
Christensen TD, Vad H, Pedersen S, Licht PB, Nybo M, Hornbech K, Zois NE, Hvas AM. Video-assisted Thoracoscopic surgery (VATS) lobectomy for lung cancer does not induce a procoagulant state. Thromb J. 2017 Dec 20;15:29. doi: 10.1186/s12959-017-0152-2. eCollection 2017.
Results Reference
derived
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Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer
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