Prognostic value of modified thrombelastometry for thromboembolic risk stratification in neurosurgical patients: protocol for a prospective, multicenter, observational study (TENS).
9 affiliations
- 1Faculty of Medicine, Department of Anaesthesiology and Operative Intensive Care Medicine, University Hospital of Cologne, Cologne, Germany. [email protected].
- 2Department of Anaesthesiology, University Hospital of Munich (LMU), Munich, Germany.
- 3Department of Anaesthesiology, Intensive Care and Emergency Medicine, DONAUISAR Hospital, Deggendorf, Germany.
- 4Department of Anaesthesiology, Intensive Care, Emergency Medicine and Pain Therapy, Klinikum and Carl von Ossietzky University Oldenburg, Oldenburg, Germany.
- 5Department of Anaesthesiology, University Hospital Klinikum rechts der Isar, TU München, Munich, Germany.
- 6Faculty of Medicine, Department of General Neurosurgery, University Hospital of Cologne, Cologne, Germany.
- 7Faculty of Medicine, Department of Anaesthesiology and Operative Intensive Care Medicine, University Hospital of Cologne, Cologne, Germany.
- 8Faculty of Medicine, Department of Neurosurgery, University Hospital of Berlin, Charité, Berlin, Germany.
- 9Institute for Medical Statistics and Bioinformatics (IMSB), Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany.
Abstract
Background and objectives
Neurosurgical patients, particularly those with intracranial tumours such as glioma or meningioma, face a markedly elevated risk of venous thromboembolism (VTE), with reported rates of deep vein thrombosis between 15% and 70% depending on tumour entity and surgical extent. Current prophylactic strategies rely predominantly on pharmacological and mechanical measures and do not account for the individual complexity of coagulation dynamics. Modified thromboelastometry, employing a low-dose tissue plasminogen activator (TPA) test, enables functional assessment of both fibrinolytic capacity and prothrombotic states at the point of care. We hypothesize that preoperative and perioperative thromboelastometric parameters - in particular lysis time (LT) in the low-dose TPA test - are associated with the occurrence of thromboembolic events in neurosurgical patients.Methods
TENS is a prospective, multicenter, observational prognostic factor study targeting 350 evaluable participants (up to 369 enrolled to account for attrition) across four university hospitals in Cologne, Munich (two centres), and Oldenburg. Eligible patients are adults (≥ 18 years) scheduled for neurosurgical procedures involving intracranial tumour resection or with an anticipated operative duration of ≥ 4 h. Thromboelastometric measurements (EXTEM, INTEM, FIBTEM, low-dose TPA test) are performed at three defined time points: before surgery, at the end of surgery, and on postoperative day 1. The primary objective is to assess the prognostic association between lysis time (LT) in the low-dose TPA test and objectively imaging-confirmed venous thromboembolic events occurring within 30 days after surgery. Secondary endpoints comprise further thromboelastometric parameters, standard coagulation laboratory values, and clinical outcomes including length of hospital stay, duration of surgery, ICU stay, and days at home at day 30.Conclusions
Modified thromboelastometry has the potential to improve individualised risk stratification for thromboembolism in neurosurgical patients. If lysis time in the low-dose TPA test demonstrates prognostic value for thromboembolic events, this could inform the development of novel diagnostic and therapeutic algorithms for high-risk surgical populations.Trial registration, date
Deutsches Register Klinischer Studien (DRKS), No. DRKS00034388, registered October 8, 2024. Anonymised participant-level data and the statistical analysis code will be made available upon reasonable request to the corresponding author following publication of the primary results, subject to applicable data protection regulations and the terms of the institutional data sharing agreement (see chapter The full study protocol will be publicly accessible via the German Clinical Trials Register (DRKS, No. DRKS00034388).Trial status
The study is currently in active recruitment. Recruitment was initiated at the coordinating centre in Cologne on 19 December 2024, with additional centres opening after completion of their local approval and site-initiation processes. As of March 2026, fewer than 50% of the target sample of 350 evaluable participants had been enrolled. Recruitment is expected to be completed by March 2027.
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BibTeX
@article{heiroth2026prognostic,
title = {{Prognostic value of modified thrombelastometry for thromboembolic risk stratification in neurosurgical patients: protocol for a prospective, multicenter, observational study (TENS).}},
author = {Hi-Jae Heiroth and Philipp Groene and Simon Schäfer and Matthias Längin and Kristina Fuest and Marion Hof and Jonas Alfitian and Tobias Brezina and Philipp Omuro and Saeed Torabi and Giusi Rueß-Paterno and Anne Göke and Simone Werschnik and Moritz Lenschow and Volker Neuschmelting and Anna Hagemeier and Tobias Kammerer},
journal = {Diagnostic and prognostic research},
year = {2026},
month = nov,
doi = {10.1186/s41512-026-00244-9},
url = {https://europepmc.org/article/MED/42968126},
note = {CC BY},
}
RIS
TY - JOUR
TI - Prognostic value of modified thrombelastometry for thromboembolic risk stratification in neurosurgical patients: protocol for a prospective, multicenter, observational study (TENS).
AU - Hi-Jae Heiroth
AU - Philipp Groene
AU - Simon Schäfer
AU - Matthias Längin
AU - Kristina Fuest
AU - Marion Hof
AU - Jonas Alfitian
AU - Tobias Brezina
AU - Philipp Omuro
AU - Saeed Torabi
AU - Giusi Rueß-Paterno
AU - Anne Göke
AU - Simone Werschnik
AU - Moritz Lenschow
AU - Volker Neuschmelting
AU - Anna Hagemeier
AU - Tobias Kammerer
PY - 2026
DA - 2026/11/02
JO - Diagnostic and prognostic research
DO - 10.1186/s41512-026-00244-9
UR - https://europepmc.org/article/MED/42968126
AB - Background and objectives Neurosurgical patients, particularly those with intracranial tumours such as glioma or meningioma, face a markedly elevated risk of venous thromboembolism (VTE), with reported rates of deep vein thrombosis between 15% and 70% depending on tumour entity and surgical extent. Current prophylactic strategies rely predominantly on pharmacological and mechanical measures and do not account for the individual complexity of coagulation dynamics. Modified thromboelastometry, employing a low-dose tissue plasminogen activator (TPA) test, enables functional assessment of both fibrinolytic capacity and prothrombotic states at the point of care. We hypothesize that preoperative and perioperative thromboelastometric parameters - in particular lysis time (LT) in the low-dose TPA test - are associated with the occurrence of thromboembolic events in neurosurgical patients.Methods TENS is a prospective, multicenter, observational prognostic factor study targeting 350 evaluable participants (up to 369 enrolled to account for attrition) across four university hospitals in Cologne, Munich (two centres), and Oldenburg. Eligible patients are adults (≥ 18 years) scheduled for neurosurgical procedures involving intracranial tumour resection or with an anticipated operative duration of ≥ 4 h. Thromboelastometric measurements (EXTEM, INTEM, FIBTEM, low-dose TPA test) are performed at three defined time points: before surgery, at the end of surgery, and on postoperative day 1. The primary objective is to assess the prognostic association between lysis time (LT) in the low-dose TPA test and objectively imaging-confirmed venous thromboembolic events occurring within 30 days after surgery. Secondary endpoints comprise further thromboelastometric parameters, standard coagulation laboratory values, and clinical outcomes including length of hospital stay, duration of surgery, ICU stay, and days at home at day 30.Conclusions Modified thromboelastometry has the potential to improve individualised risk stratification for thromboembolism in neurosurgical patients. If lysis time in the low-dose TPA test demonstrates prognostic value for thromboembolic events, this could inform the development of novel diagnostic and therapeutic algorithms for high-risk surgical populations.Trial registration, date Deutsches Register Klinischer Studien (DRKS), No. DRKS00034388, registered October 8, 2024. Anonymised participant-level data and the statistical analysis code will be made available upon reasonable request to the corresponding author following publication of the primary results, subject to applicable data protection regulations and the terms of the institutional data sharing agreement (see chapter The full study protocol will be publicly accessible via the German Clinical Trials Register (DRKS, No. DRKS00034388).Trial status The study is currently in active recruitment. Recruitment was initiated at the coordinating centre in Cologne on 19 December 2024, with additional centres opening after completion of their local approval and site-initiation processes. As of March 2026, fewer than 50% of the target sample of 350 evaluable participants had been enrolled. Recruitment is expected to be completed by March 2027.
SN - 2397-7523
ER -