Optimizing Anti Coagulant Therapy in Neurosurgical Interventions in Patients with an Increased Risk for Thrombo-embolic Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intracranial surgery;
- •Tumour surgery (spinal or intracranial);
- •>180 min estimated surgical intervention time;
- •>240 min time under anaesthesia;
- •Spine trauma surgery;
排除标准
- •• Age under 18 years;
- •Perioperative continuation of anti coagulant therapy indicated other than prophylactic LMWH;
研究组 & 干预措施
Fraxiparine
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.
干预措施: Fraxiparine (Drug)
IPD
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).
干预措施: IPD Device delivered by Converis (Device)
IPD
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).
干预措施: Fraxiparine (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Clinical signs of DVT i.e. swollen,painful and red leg or pulmonary embolism(2 months)
- Quality of life by EQ-5D(2 mos after surgery)
- Patient perceived recovery with Likert scale(2 months)
- prevalence of DVT measured by duplex/doppler routinely performed in the whole study population(1 week)
- Cost effectiveness with EQ-5D and estimated costs in cost diaries(2 months)
研究者
C.L.A.Vleggeert-Lankamp
MD MSc PhD
Leiden University Medical Center