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 - a randomized controlled trial.

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 - a randomized controlled trial. - TABASCO

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033515

Enrollment

276

Registered

2024-02-05

Start date

2024-02-01

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

I62.02

Interventions

Group 1: Postoperative adjuvant drug therapy with tranexamic acid Group 2: Postoperative adjuvant embolization of the middle meningeal artery on the affected side using digital subtraction angiography

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. patients who underwent surgery for unilateral cSDH for the first time no more than 24 hours before inclusion in the study. 2. written consent to participate in the study by the patient or a legal representative

Exclusion criteria

Exclusion criteria: 1. Conservatively treated cSDH 2. Bilateral cSDH 3. Age < 18 years 4. Pregnancy or breastfeeding 5. radiological evidence of an acute subdural hematoma, subarachnoid hemorrhage, epidural or intracerebral hematoma 6. structural causes of subdural hemorrhages, e.g. arachnoid cysts, cortical vascular malformations 7. Lack of patient information in the absence of legal guardianship 8. inability to perform angiography/embolization within 72 hours of the operation if there are contraindications to taking tranexamic acid (inability to cross over) 9. Embolization not technically feasible 10. Condition after borehole trepanation, craniotomies and craniectomies for other reasons in the past

Design outcomes

Primary

Measure	Time frame
Postoperative volume decrease of a primarily surgically relieved cSDH quantitatively and with regard to the time course in the follow-up period of 3 months	—

Secondary

Measure	Time frame
1. the rate of necessary revision surgery of a primarily surgically relieved cSDH in the follow-up period of 3 months 2. constellations of findings with regard to neurological deficits, recorded using NIHSS and CT morphological changes, which led to the indication for revision surgery in patients included in the study 3. the neurological outcome measured using the modified RedkinScale (mRS) 3 months after study inclusion 4. number of procedure-associated complications over time 3 months after inclusion in the study	—

Measure

Time frame

1. the rate of necessary revision surgery of a primarily surgically relieved cSDH in the follow-up period of 3 months 2. constellations of findings with regard to neurological deficits, recorded using NIHSS and CT morphological changes, which led to the indication for revision surgery in patients included in the study 3. the neurological outcome measured using the modified RedkinScale (mRS) 3 months after study inclusion 4. number of procedure-associated complications over time 3 months after inclusion in the study

—

Countries

Germany

Contacts

Public ContactMagnus Scheer

Klinik für Neurochirurgie Bundeswehrkrankenhaus Ulm

magnusscheer@bundeswehr.org+497311710-37012

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026