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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: Dalteparin (Fragmin®)
Dalteparin (Fragmin®) 5000 IU (International Unit) once daily
Drug: Dalteparin (Fragmin®)
No Intervention: No treatment
Open surgery arm
Dalteparin (Fragmin®) 5000 IU once daily
Drug: Dalteparin (Fragmin®)
- 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)
- 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].
- 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.
- 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).
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
|Aarhus University Hospital|
|Aarhus, Denmark, 8200|
|Odense University Hospital|
|Principal Investigator:||Thomas D Christensen, MD||Aarhus University Hospital|