A Phase 4 interventional study of Dalteparin (Fragmin®) in Lung Cancer, sponsored by Thomas Decker Christensen. Completed at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-23.
Sponsored by Thomas Decker Christensen · Phase 4, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 116 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Thomas Decker Christensen is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dalteparin (Fragmin®) 5000 IU (International Unit) once daily
Drug: Dalteparin (Fragmin®)
No treatment
Dalteparin (Fragmin®) 5000 IU once daily
Drug: Dalteparin (Fragmin®)
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)
Time frame: 30 days
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) \[min\].
Time frame: 30 days
Standard coagulation analysis
APTT (activated partial thromboplastin time), INR (International Normalized Ratio), fibrinogen, fibrin d-dimer, thrombin time, thrombocytes and Factor VIII: clot.
Time frame: 30 days
Thrombocyte function analysis
analysis on Multiplate®, where the thrombocyte aggregation are expressed as Aggregation unit (AU), area under curve (A\*min).
Time frame: 30 days
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Thomas Decker Christensen