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…
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 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 peroperative
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 peroperative 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 peroperative
intermittent pneumatic compression of the legs and if so, what is the
cost-effectiveness?
Background summary
Postoperative venous thrombosis is a serious complication in surgical patients
that is accompanied by a high morbidity and mortality rate. Venous
thromboembolism (VTE) usually affects the deep veins of the leg. Pulmonary
embolus (PE) is a life threatening complication of VTE. During and after
surgery the patient has an increased risk for VTE, as a consequence of
immobilization causing stasis of blood, which possibly leads to local hypoxia
and subsequent endothelial damage.
In neurosurgical patients, the risk for 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 mobilise. Moreover, intracranial and intraspinal tumours and subarachnoid
haemorrhage cause hypercoagulability, which increases the risk on VTE. A study
that was recently performed in the United States demonstrated that
postoperative thromboembolic events are the second most occurring complication
in surgery, the second most occurring cause of excess length of stay, and the
third most occurring cause of morbidity and mortality in hospitalized patients
in general.
Study objective
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 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.
Study design
A randomized controlled trial on high-risk neurosurgical patients in a
University hospital
Study burden and risks
Follow up of all patients will be performed at 3-7 days after surgery, during
admission time. At this time all patient will have a duplex ultrasound
examination to asses the prevalence of a possible deep venous thrombosis.
Albinusdreef 2
2333 ZA Leiden 2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden 2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Intracranial, tumour or trauma surgery,
>180 min estimates surgical intervention time
>240 min time under anaesthesia
Exclusion criteria
Age under 18 years
Perioperative continuation of anti coagulant therapy indicated other than
prophylactic low molecular weight heparin
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56552.058.16 |