Deep-Venous ThrombosisTIPOTEENCT02987946
Leiden Trial in Prevention of Post-Operative ThromboEmbolic Events
A study testing IPD Device delivered by Converis and Fraxiparine in people with Deep-Venous Thrombosis, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
In neurosurgical patients, the risk for venous thromboembolic events (VTE) is high due to the relatively long duration of surgery, the high occurrence of prolonged immobilization of patients due to paresis of the legs or intracranial pathology causing inability to mobilise2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep-Venous Thrombosis
- What is being tested?
- IPD Device delivered by Converis and Fraxiparine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2016to Sep 2024
- Phase
- Interventional
- 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
- Tumour surgery (spinal or intracranial);
- >180 min estimated surgical intervention time;
- >240 min time under anaesthesia;
- Spine trauma surgery;
Who cannot join
- • Age under 18 years;
- Perioperative continuation of anti coagulant therapy indicated other than prophylactic LMWH;
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Centre
Leiden, South Holland, 2300RC
About this study
Official title: Optimizing Anti Coagulant Therapy in Neurosurgical Interventions in Patients with an Increased Risk for Thrombo-embolic Complications
In neurosurgical patients, the risk for venous thromboembolic events (VTE) is high due to the relatively long duration of surgery, the high occurrence of prolonged immobilization of patients due to paresis of the legs or intracranial pathology causing inability to mobilise2. Moreover, intracranial and intraspinal tumours and subarachnoid haemorrhage cause hypercoagulability, which increases the risk on VTE. There is a high degree of diversity in attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity, insufficient power of performed studies and lack of careful phenotyping and description of risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with adequate power and detailed information on patient related factors (malignancy, subarachnoid haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and postoperative immobilisation will allow us to identify the optimal treatment strategy for high risk neurosurgical patients.
In the current study all patients that fulfil the inclusion criteria will be subjected to post-operative systematic evaluation of VTE by echo-duplex investigation.
Read the detailed description
It is clear that thrombo-embolic prophylaxis is mandatory in neurosurgical interventions. The current prophylactic strategy using preoperatively started low molecular-weight heparine (LMWH) allows still a considerable number of thrombo-embolic complications, in particular in those patients that are subjected to prolonged neurosurgical interventions. Guidelines advise mechanical prophylaxis. However, these guidelines are based on literature with low grade of evidence. To achieve the highest grade of evidence we will randomize subsequent patients between intermittent compression stockings with preoperative LMWH prophylaxis, and LMWH as stand alone prophylaxis. The last, being the current state of practice in all neurosurgical patients in our ward, including the high thrombosis risk group. All patients will receive preoperatively started LMWH.
There is a high degree of diversity in attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity, insufficient power of performed studies and lack of careful phenotyping and description of risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with adequate power and detailed information on patient related factors (malignancy, subarachnoid haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and postoperative immobilisation will allow us to identify the optimal treatment strategy for high risk neurosurgical patients.
In the current study all patients that fulfil the inclusion criteria will be subjected to post-operative systematic evaluation of venous thromboembolic events (VTE) by echo-duplex investigation.
- 2. Goal of the study The primary goal of the current study is to investigate whether the combination of perioperative intermittent pneumatic compression and LMWH has a lower incidence of postoperative thrombo-embolic complications within a week after a high risk neurosurgical intervention in comparison to patients receiving merely LMWH prophylaxis.
Secondary research questions are:
- Is there a difference in number of patients with clinical symptoms of thromboembolus in patients receiving the combination of peroperative intermittent pneumatic compression of the lower limbs and LMWH in comparison to patients receiving merely LMWH prophylaxis in high risk neurosurgical patients, scored two months after surgery;
- What is the prevalence of VTE in high risk neurosurgical patients in the Leiden University Medical Centre (LUMC) receiving LMWH prophylaxis;
- What are the risk factors for the prevalence of VTE in high risk neurosurgical patients in the LUMC;
- What is the incidence of bleeding complications in high risk neurosurgical patients in the LUMC receiving LMWH prophylaxis;
- Is there a difference in length of hospital stay in patients receiving the combination of peroperative intermittent pneumatic compression of the lower limbs and LMWH in comparison to patients receiving merely LMWH prophylaxis in high risk neurosurgical patients;
- Is there a difference in patient perceived recovery at discharge and at 2 month follow up in patients receiving the combination of perioperative intermittent pneumatic compression and LMWH in comparison to patients receiving merely LMWH prophylaxis in high risk neurosurgical patients;
- Is there a difference in Quality of life at discharge and at 2 month follow up in patients receiving the combination of perioperative intermittent pneumatic compression of the legs and LMWH in comparison to patients receiving merely LMWH prophylaxis in high-risk neurosurgical patients;
- Is it relevant to consider cost-effectiveness of the use of perioperative intermittent pneumatic compression of the legs and if so, what is the cost-effectiveness?
- 3. Randomized controlled trial This is a randomized controlled trial on high-risk neurosurgical patients in a University hospital (see inclusion and exclusion criteria) in which consecutive patients who meet the inclusion criteria are invited to participate in the trial. Clinical and demographic data are gathered, as well as surgical details and prevailing complications. Postoperative bleeding requiring secondary surgery or lengthening of hospital stay will be documented as a clinically relevant bleeding complication. All patients receive Fraxiparine 2850 IU (international units) daily, starting preoperatively compatible with current practice. At admission patients will be randomized to be subjected to perioperative (48 hrs) intermittent pneumatic compression or standard care. Following current guidelines in the LUMC the Fraxiparine dose is doubled to 5600 IU in patients with a weight above 100 kg.
All randomized patients will receive a postoperative doppler examination of the major veins of both lower limb in order to identify a possible VTE. A post-operative thrombo-embolic complication is defined as follows7:
- Asymptomatic VTE confirmed by echo Doppler;
- Symptomatic VTE confirmed by echo Doppler;
- Symptomatic pulmonary embolism (PE) confirmed by CT scan
- Fatal pulmonary embolism confirmed by autopsy
> 3.1 Population The neurosurgical patient has an increased risk on thrombo-embolic complications because he is subjected to an intervention that in general takes a long time and causes the patient to be immobilized during a longer period (during and directly after surgery). Moreover, the pathology is frequently carcinomatous, having an increased risk for thrombo-embolic events by nature. The in- and exclusion criteria are aiming at these properties of the patients. All consecutive patients that fulfil the criteria will be invited to participate in this study. In order to be included the patient has to sign an informed consent. Based on a power analysis 140 patients in both randomization arms have to be included (based on a VTE incidence of 15% which will decrease to 5% after treatment with intermittent pneumatic leg pumps during surgery; alpha 0.05, power 80%) to be able to obtain a significant effect.
- Conditions
- Deep-Venous Thrombosis
- Being tested
- IPD Device delivered by Converis, Fraxiparine
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPD Device delivered by ConverisDevice
Also called IPD
After randomization patients will be subjected to perioperative (48 hrs) intermittent pneumatic compression.
FraxiparineDrug
Also called LMWH
All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice.
| Study group | Role | What they receive |
|---|---|---|
| Fraxiparine | Active comparator | Intervention: All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice. After randomization the patients in this arm will be subjected to fraxipareine 2850 IE daily. According to current guidelines in the LUMC the Fraxiparine dose is doubled to 5600 IE in patients with a weight above 100 kg. Receives: Drug: Fraxiparine |
| IPD | Experimental | Intervention: IPD Device: After randomization the patients in this arm will be subjected to fraxiparine 2850 IE daily and intermittent pressure devices for at least 48 hours or until mobilization. The intermittent pressure device is a leg pump delivered by Converis(R). Receives: Device: IPD Device delivered by Converis; Drug: Fraxiparine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower incidence of thromboembolic complications in patients with IPD + LMWH by adding IPD to usual care, established with systematic doppler/duplex evaluation in all patients at 5 +/- 2 days post surgery
The primary goal of the current study is to investigate whether the combination of perioperative intermittent pneumatic compression and LMWH has a lower incidence of postoperative thrombo-embolic complications within a week after a high risk neurosurgical intervention in comparison to patients receiving merely LMWH prophylaxis. All patients will be subjected to doppler/duplex in the week after surgery. Follow up of all patients will be performed at 5 +/- 2 days after surgery, during admission time. At this time all patient will have a duplex ultrasound examination to assess the prevalence of a possible deep venous thrombosis. This period has been chosen in analogy with existing literature (appendix A). 9-15 For this examination patients have to be able stand upright. Therefore in some cases (e.g ICU patients) the interval will be longer, with a maximum of 20 days.
Measured: 1 week
Secondary outcomes (5)
prevalence of DVT measured by duplex/doppler routinely performed in the whole study population
Measured: 1 week
Clinical signs of DVT i.e. swollen,painful and red leg or pulmonary embolism
Measured: 2 months
Quality of life by EQ-5D
Measured: 2 mos after surgery
Patient perceived recovery with Likert scale
Measured: 2 months
Cost effectiveness with EQ-5D and estimated costs in cost diaries
is the additional use of IPD cost effective in prevention of DVT in neurosurgical patients
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2023
- Study completionSep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep-Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, C.L.A.Vleggeert-Lankamp, Leiden University Medical Center
- Investigators
- Carmen Vleggeert-Lankamp, MD MSc PhD, Principal investigator, Leiden University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987946
- Sponsor's protocol ID
- NL56552.058.16
- Acronym
- TIPOTEE
- Status last verified
- Jun 2024
- First submitted
- 16 Nov 2016
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Anti Coagulant Therapy in Neurosurgical Interventions in Patients with an Increased Risk for Thrombo-embolic Complications
- ClinicalTrials.gov ID
- NCT02987946
- Acronym / sponsor ID
- TIPOTEE / NL56552.058.16
- Conditions
- Deep-Venous Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 9 Dec 2016 (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.
In neurosurgical patients, the risk for venous thromboembolic events (VTE) is high due to the relatively long duration of surgery, the high occurrence of prolonged immobilization of patients due to paresis of the legs or intracranial pathology causing inability to mobilise2. Moreover, intracranial and intraspinal tumours and subarachnoid haemorrhage cause hypercoagulability, which increases the risk on VTE. There is a high degree of diversity in attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity, insufficient power of performed studies and lack of careful phenotyping and description of risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with adequate power and detailed information on patient related factors (malignancy, subarachnoid haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and postoperative immobilisation will allow us to identify the optimal treatment strategy for high risk neurosurgical patients.
In the current study all patients that fulfil the inclusion criteria will be subjected to post-operative systematic evaluation of VTE by echo-duplex investigation.
Detailed description
It is clear that thrombo-embolic prophylaxis is mandatory in neurosurgical interventions. The current prophylactic strategy using preoperatively started low molecular-weight heparine (LMWH) allows still a considerable number of thrombo-embolic complications, in particular in those patients that are subjected to prolonged neurosurgical interventions. Guidelines advise mechanical prophylaxis. However, these guidelines are based on literature with low grade of evidence. To achieve the highest grade of evidence we will randomize subsequent patients between intermittent compression stockings with preoperative LMWH prophylaxis, and LMWH as stand alone prophylaxis. The last, being the current state of practice in all neurosurgical patients in our ward, including the high thrombosis risk group. All patients will receive preoperatively started LMWH.
There is a high degree of diversity in attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity, insufficient power of performed studies and lack of careful phenotyping and description of risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with adequate power and detailed information on patient related factors (malignancy, subarachnoid haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and postoperative immobilisation will allow us to identify the optimal treatment strategy for high risk neurosurgical patients.
In the current study all patients that fulfil the inclusion criteria will be subjected to post-operative systematic evaluation of venous thromboembolic events (VTE) by echo-duplex investigation.
- 2. Goal of the study The primary goal of the current study is to investigate whether the combination of perioperative intermittent pneumatic compression and LMWH has a lower incidence of postoperative thrombo-embolic complications within a week after a high risk neurosurgical intervention in comparison to patients receiving merely LMWH prophylaxis.
Secondary research questions are:
- Is there a difference in number of patients with clinical symptoms of thromboembolus in patients receiving the combination of peroperative intermittent pneumatic compression of the lower limbs and LMWH in comparison to patients receiving merely LMWH prophylaxis in high risk neurosurgical patients, scored two months after surgery;
- What is the prevalence of VTE in high risk neurosurgical patients in the Leiden University Medical Centre (LUMC) receiving LMWH prophylaxis;
- What are the risk factors for the prevalence of VTE in high risk neurosurgical patients in the LUMC;
- What is the incidence of bleeding complications in high risk neurosurgical patients in the LUMC receiving LMWH prophylaxis;
- Is there a difference in length of hospital stay in patients receiving the combination of peroperative intermittent pneumatic compression of the lower limbs and LMWH in comparison to patients receiving merely LMWH prophylaxis in high risk neurosurgical patients;
- Is there a difference in patient perceived recovery at discharge and at 2 month follow up in patients receiving the combination of perioperative intermittent pneumatic compression and LMWH in comparison to patients receiving merely LMWH prophylaxis in high risk neurosurgical patients;
- Is there a difference in Quality of life at discharge and at 2 month follow up in patients receiving the combination of perioperative intermittent pneumatic compression of the legs and LMWH in comparison to patients receiving merely LMWH prophylaxis in high-risk neurosurgical patients;
- Is it relevant to consider cost-effectiveness of the use of perioperative intermittent pneumatic compression of the legs and if so, what is the cost-effectiveness?
- 3. Randomized controlled trial This is a randomized controlled trial on high-risk neurosurgical patients in a University hospital (see inclusion and exclusion criteria) in which consecutive patients who meet the inclusion criteria are invited to participate in the trial. Clinical and demographic data are gathered, as well as surgical details and prevailing complications. Postoperative bleeding requiring secondary surgery or lengthening of hospital stay will be documented as a clinically relevant bleeding complication. All patients receive Fraxiparine 2850 IU (international units) daily, starting preoperatively compatible with current practice. At admission patients will be randomized to be subjected to perioperative (48 hrs) intermittent pneumatic compression or standard care. Following current guidelines in the LUMC the Fraxiparine dose is doubled to 5600 IU in patients with a weight above 100 kg.
All randomized patients will receive a postoperative doppler examination of the major veins of both lower limb in order to identify a possible VTE. A post-operative thrombo-embolic complication is defined as follows7:
- Asymptomatic VTE confirmed by echo Doppler;
- Symptomatic VTE confirmed by echo Doppler;
- Symptomatic pulmonary embolism (PE) confirmed by CT scan
- Fatal pulmonary embolism confirmed by autopsy
> 3.1 Population The neurosurgical patient has an increased risk on thrombo-embolic complications because he is subjected to an intervention that in general takes a long time and causes the patient to be immobilized during a longer period (during and directly after surgery). Moreover, the pathology is frequently carcinomatous, having an increased risk for thrombo-embolic events by nature. The in- and exclusion criteria are aiming at these properties of the patients. All consecutive patients that fulfil the criteria will be invited to participate in this study. In order to be included the patient has to sign an informed consent. Based on a power analysis 140 patients in both randomization arms have to be included (based on a VTE incidence of 15% which will decrease to 5% after treatment with intermittent pneumatic leg pumps during surgery; alpha 0.05, power 80%) to be able to obtain a significant effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fraxiparine | Active comparator | Drug: FraxiparineIntervention: All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice. After randomization the patients in this arm will be subjected to fraxipareine 2850 IE daily. According to current guidelines in the LUMC the Fraxiparine dose is doubled to 5600 IE in patients with a weight above 100 kg. |
| IPD | Experimental | Device: IPD Device delivered by Converis, Drug: FraxiparineIntervention: IPD Device: After randomization the patients in this arm will be subjected to fraxiparine 2850 IE daily and intermittent pressure devices for at least 48 hours or until mobilization. The intermittent pressure device is a leg pump delivered by Converis(R). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Tumour surgery (spinal or intracranial);
- >180 min estimated surgical intervention time;
- >240 min time under anaesthesia;
- Spine trauma surgery;
Key exclusion criteria (2 listed)
- • Age under 18 years;
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 |
|---|---|---|
| IPD Device delivered by ConverisAlso: IPDAfter randomization patients will be subjected to perioperative (48 hrs) intermittent pneumatic compression. | Device | IPD |
| FraxiparineAlso: LMWHAll patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice. | Drug | Fraxiparine, IPD |
Primary outcome
Lower incidence of thromboembolic complications in patients with IPD + LMWH by adding IPD to usual care, established with systematic doppler/duplex evaluation in all patients at 5 +/- 2 days post surgery
Time frame: 1 week
The primary goal of the current study is to investigate whether the combination of perioperative intermittent pneumatic compression and LMWH has a lower incidence of postoperative thrombo-embolic complications within a week after a high risk neurosurgical intervention in comparison to patients receiving merely LMWH prophylaxis. All patients will be subjected to doppler/duplex in the week after surgery. Follow up of all patients will be performed at 5 +/- 2 days after surgery, during admission time. At this time all patient will have a duplex ultrasound examination to assess the prevalence of a possible deep venous thrombosis. This period has been chosen in analogy with existing literature (appendix A). 9-15 For this examination patients have to be able stand upright. Therefore in some cases (e.g ICU patients) the interval will be longer, with a maximum of 20 days.
5 secondary outcomes
prevalence of DVT measured by duplex/doppler routinely performed in the whole study population
Time frame: 1 week
Clinical signs of DVT i.e. swollen,painful and red leg or pulmonary embolism
Time frame: 2 months
Quality of life by EQ-5D
Time frame: 2 mos after surgery
Patient perceived recovery with Likert scale
Time frame: 2 months
Cost effectiveness with EQ-5D and estimated costs in cost diaries
Time frame: 2 months
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 10 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Carmen Vleggeert-Lankamp, MD MSc PhD principal investigator
Leiden University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPD Device delivered by Converis and Fraxiparine in people with Deep-Venous Thrombosis, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 inclusion and 2 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
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?
Lower incidence of thromboembolic complications in patients with IPD + LMWH by adding IPD to usual care, established with systematic doppler/duplex evaluation in all patients at 5 +/- 2 days post surgery (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2025.