Optimizing anti coagulant therapy in neurosurgical interventions in patients with an increased risk for thrombo-embolic complications.

Optimizing anti coagulant therapy in neurosurgical interventions in patients with an increased risk for thrombo-embolic complications. - TIPOTEE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55381

Enrollment

280

Registered

2016-10-05

Start date

2017-02-07

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abnormal blood clotting vasculair illness

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Intracranial, tumour or trauma surgery, >180 min estimates surgical intervention time >240 min time under anaesthesia

Exclusion criteria

Exclusion criteria: Age under 18 years Perioperative continuation of anti coagulant therapy indicated other than prophylactic low molecular weight heparin

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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?	—

Measure

Time frame

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?

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Countries

Netherlands

Outcome results