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Risk of Thromboembolism in patients undergoing craniotomy with intraoperative application of intermittent pneumatic compression of the legs: A prospective, randomized, single-blinded multicenter study

Risk of Thromboembolism in patients undergoing craniotomy with intraoperative application of intermittent pneumatic compression of the legs: A prospective, randomized, single-blinded multicenter study - TRIPCON

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034190
Enrollment
350
Registered
2024-05-02
Start date
2024-10-09
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Venous thromboembolism during craniotomy I80.2 I26

Interventions

Group 1: Intraoperative use of intermittent pneumatic compression (IPC) of the legs Group 2: No intraoperative use of IPC. The IPC-sleeves are applied identical to the treatment-group, but the airpuls

Sponsors

Martin-Luther-Universität Halle-Wittenberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Elective surgery for intracranial pathology via craniotomy

Exclusion criteria

Exclusion criteria: - Pregnancy - patients incapable of giving consent - Perioperative administration of blood products - Abnormal coagulation (platelets and/or plasmatic coagulation, liver disease, use of antiplatelet agents) - Contraindication to the use of IPC (dermatitis in the lower leg area, recent skin transplantation; severe arteriosclerosis or other ischemic vascular diseases, massive leg oedema or pulmonary oedema due to heart failure; extreme deformity of the leg) pre-existing thromboembolism Clinical signs of deep vein thrombosis

Design outcomes

Primary

MeasureTime frame
Occurrence of (symptomatic and asymptomatic) VTE (yes/no) within 7 days post-op

Secondary

MeasureTime frame
Occurrence of the following events within 7 days: - Proximal and distal deep vein thrombosis (DVT) - symptomatic VTE - asymptomatic VTE - Muscular vein thrombosis - Thrombosis associated with a central venous catheter - Pulmonary embolism - death - Influence of the type of lesion and the duration of the operation.

Countries

Germany

Contacts

Public ContactMichael Richter

Koordinierungszentrum für Klinische Studien Halle

richter.michael@kks-halle.de+493455574907

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026