Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jun 14;26(1):207.
doi: 10.1186/s13063-025-08888-6.

Tranexamic acid vs. embolization of the meningeal artery as an adjunctive therapeutic regime to reduce the recurrence rate after surgical relief of chronic subdural hematomas (TABASCO)-a randomized controlled trial

Magnus Scheer  1 , Vanessa Beuchel  2 , Uwe Max Mauer  3 , Klaus Efinger  4 , Chris Schulz  3
Affiliations

Tranexamic acid vs. embolization of the meningeal artery as an adjunctive therapeutic regime to reduce the recurrence rate after surgical relief of chronic subdural hematomas (TABASCO)-a randomized controlled trial

Magnus Scheer et al. Trials. .

Abstract

Background: Chronic subdural hematoma is a persistent, bloody to serous fluid retention in the subdural space between the dura mater and arachnoid mater, usually caused by an initial trauma, and is one of the most common traumatic intracranial hemorrhages in western industrialized nations. In the event of a compressive effect on the brain, the hematoma is usually relieved by means of a burr hole trephination. In view of the high postoperative recurrence rate, conservative treatment methods have been investigated both as a competitor to surgery alone in cases where the indication for surgery is debatable and as a supportive therapy for surgical hematoma relief. Studies on embolization of the middle meningeal artery during surgery as well as studies on postoperative drug therapy using tranexamic acid have shown the most promise. However, there is currently a lack of studies that randomly compare the effectiveness of these two perioperative treatment strategies regarding to their efficacy in avoiding revision surgery and the safety of the respective procedure.

Methods: TABASCO is a prospective, randomized, two-arm, multicenter, clinical trial designed to determine whether postoperative treatment of chronic subdural hematomas using adjuvant drug therapy with tranexamic acid (test group) is equivalent to postoperative embolization of the arteria meningea media (control group) in terms of postoperative volume reduction of the hematoma and the need for revision surgery of CSDH. Patients over 18 years of age who have undergone surgery for CSDH for the first time no more than 24 h before inclusion in the study will be randomized 1:1 to the test group or control group. The primary endpoint is the postoperative volume decrease of a primarily surgically relieved CSDH quantitatively and regarding to the time course on the affected side in a study period of 3 months postoperatively. The secondary endpoint of this study is to investigate the extent to which the rate of necessary revision surgery can be influenced by the adjuvant therapy procedures over the course of 3 months. The tertiary endpoint is the neurological outcome of the patients included in the study and assigned to the different treatment arms after a total follow-up period of 3 months as well as the complication rate of the adjuvant procedures used. Assuming a risk difference of 8% for rebleeding and surgical revision, with an applied power of 80%, 276 patients (138 per group) will be included in this study.

Discussion: The TABASCO study will provide clinical evidence as to whether embolization of the middle meningeal artery in addition to surgery is comparable to postoperative drug therapy using tranexamic acid as an adjuvant treatment method for operated chronic subdural hematomas in terms of hematoma volume reduction, revision rate and safety of the procedures.

Trial registration: German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) DRKS00033515. Registered on 05 Feb 2024.

Keywords: Chronic subdural hematoma; Embolization; Endovascular; Middle meningeal artery; Mild traumatic brain injury; Randomized controlled trial; Surgery; Tranexamic acid.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate {24}: This study has been ethically approved by the ethic committee of the University of Ulm, Germany, on 15 January 2024 (396/23-FSt/Sta). All participants must give their informed written consent prior to participation. Informed consent materials {32}: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request. Competing interests {28}: The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Steps that have to be carried out, before potential participations can be enrolled in the study
Fig. 2
Fig. 2
Preoperative volume measurement of a right-sided hemispheric chronic subdural hematoma using the CT data set
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Davies JM, Knopman J, Mokin M, Hassan AE, Harbaugh RE, Khalessi A, Fiehler J, Gross BA, Grandhi R, Tarpley J, Sivakumar W, Bain M, Crowley RW, Link TW, Fraser JF, Levitt MR, Chen PR, Hanel RA, Bernard JD, Jumaa M, Youssef P, Cress MC, Chaudry MI, Shakir HJ, Lesley WS, Billingsley J, Jones J, Koch MJ, Paul AR, Mack WJ, Osbun JW, Dlouhy K, Grossberg JA, Kellner CP, Sahlein DH, Santarelli J, Schirmer CM, Singer J, Liu JJ, Majjhoo AQ, Wolfe T, Patel NV, Roark C, Siddiqui AH, EMBOLISE Investigators. Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma. N Engl J Med. 2024;391(20):1890–900. - PubMed
    1. de Paula M, Ribeiro BDC, Melo MM, de Freitas PVV, Pahl FH, de Oliveira MF, et al. Effect of postoperative tranexamic acid on recurrence rate and complications in chronic subdural hematomas patients: preliminary results of a randomized controlled clinical trial. Neurosurg Rev. 2023;46(1):90. - PMC - PubMed
    1. Edlmann E, Giorgi-Coll S, Whitfield PC, Carpenter KLH, Hutchinson PJ. Pathophysiology of chronic subdural haematoma: inflammation, angiogenesis and implications for pharmacotherapy. J Neuroinflammation. 2017;14(1):108. - PMC - PubMed
    1. European Medicines Agency (EMA). Guideline on missing data in confirmatory clinical trials. 2011; 1–12.
    1. Fachinformation Cyklokapron ®, 500 mg Filmtabletten, MEDA Pharma GmBH und Co. KG, 07/2016: 1–3.

Publication types

MeSH terms

LinkOut - more resources