Lung CancerPhase 4COPPVATSNCT01741506
Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer
A Phase 4 study testing Dalteparin (Fragmin®) in people with Lung Cancer, run by Thomas Decker Christensen at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Dalteparin (Fragmin®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 3 sitesDenmark
- Study dates
- Mar 2013to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital
Aarhus, Aarhus, 8200
Rigshospitalet
Copenhagen
Odense University Hospital
Odense
About this study
Official title: Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer - A Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Dalteparin (Fragmin®)
- Keywords
- Lung cancer, Surgery, Thromboembolism, Bleeding
- Medical subject headings
- Lung Neoplasms, Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalteparin (Fragmin®)Drug
| Study group | Role | What they receive |
|---|---|---|
| Dalteparin (Fragmin®) | Experimental | Dalteparin (Fragmin®) 5000 IU (International Unit) once daily Receives: Drug: Dalteparin (Fragmin®) |
| No treatment | No intervention | No treatment |
| Open surgery arm | Other | Dalteparin (Fragmin®) 5000 IU once daily Receives: Drug: Dalteparin (Fragmin®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (1)
Thrombin generation
- 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].
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Decker Christensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Decker Christensen, Aarhus University Hospital
- Investigators
- Thomas D Christensen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741506
- Sponsor's protocol ID
- COPPVATS vs 1.1
- Other IDs
- 2012-002409-23
- Acronym
- COPPVATS
- Status last verified
- Apr 2015
- First submitted
- 25 Nov 2012
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29270080
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Profile in Patients Undergoing Video Assisted Thorascopic Surgery (VATS) for Lung Cancer - A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01741506
- Acronym / sponsor ID
- COPPVATS / COPPVATS vs 1.1
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Surgery, Thromboembolism, Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Thomas Decker ChristensenUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dalteparin (Fragmin®) | Experimental | Drug: Dalteparin (Fragmin®)Dalteparin (Fragmin®) 5000 IU (International Unit) once daily |
| No treatment | No intervention | –No treatment |
| Open surgery arm | Other | Drug: Dalteparin (Fragmin®)Dalteparin (Fragmin®) 5000 IU once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dalteparin (Fragmin®) | Drug | Dalteparin (Fragmin®), Open surgery arm |
Primary outcome
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)
1 secondary outcome
Thrombin generation
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Derived from this study: PubMed 29270080Christensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas D Christensen, MD principal investigator
Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalteparin (Fragmin®) in people with Lung Cancer, run by Thomas Decker Christensen at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboelastometry (ROTEM®) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01741506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.