A clinical trial to assess if cortison helps to avoid a reoperation in patients which are operated for chronic subdural hematoma.

DRES - A prospective, multi-center, double blind, randomized, placebo controlled study to assess the efficacy of Dexamethason in reducing the reoperation rate in patients with chronic subdural hematoma. - DRES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003544-42-AT

Enrollment

790

Registered

2011-11-17

Start date

2012-02-16

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

operated chronic subdural hematoma MedDRA version: 18.0 Level: LLT Classification code 10049163 Term: Chronic subdural hematoma System Organ Class: 100000004863

Interventions

Trade Name: Fortecortin 4mg-Tabletten Product Name: Fortecortin 4mg-Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: Dexamethason Current Sponsor code: 7075 Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Males and females over the age of 25 All patients, who are operated for chronic subdural hematoma Written informed consent to participate in the study must be obtained from the patient or a legal representative prior to initiation of any study-mandated procedure and randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 820 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 820

Exclusion criteria

Exclusion criteria: Pregnancy and nursing Diabetes Hypertension > 180mmHg syst. despite medicamentous therapy Hypersensitivity of dexamethason Peptic ulceration Acute systemic infection Parasitic infections Patients for whom it is known, at the time of screening, that certain follow up, protocol-mandated imaging assessments will not be feasible Patients unlikely to comply with the protocol (e.g., unable to return for-follow up visits).

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that dexamethson reduces the reoperation rate for 50% within 12 weeks after hematoma evacuation;Secondary Objective: To evaluate that dexamethason improves clinical outcome during a period of 12 weeks after surgery, as measured by the Markwalder score To evaluate if dexamethason provokes a faster clinical improvement postoperative To evaluate the impact of dexamethason on the thickness of the hematoma, its membranes and mass demanding effect (midline-shift). ;Primary end point(s): Reoperation between 48 hours and 12 weeks after the primal operation;Timepoint(s) of evaluation of this end point: Reoperation between 48 hours and 12 weeks after the primal operation	—

Measure

Time frame

Main Objective: To demonstrate that dexamethson reduces the reoperation rate for 50% within 12 weeks after hematoma evacuation;Secondary Objective: To evaluate that dexamethason improves clinical outcome during a period of 12 weeks after surgery, as measured by the Markwalder score To evaluate if dexamethason provokes a faster clinical improvement postoperative To evaluate the impact of dexamethason on the thickness of the hematoma, its membranes and mass demanding effect (midline-shift). ;Primary end point(s): Reoperation between 48 hours and 12 weeks after the primal operation;Timepoint(s) of evaluation of this end point: Reoperation between 48 hours and 12 weeks after the primal operation

—

Secondary

Measure	Time frame
Secondary end point(s): Clinical improvement measured by the Markwalder-score Reduction of the thickness of hematoma or midline-shift Reduction of the membranes, if present ;Timepoint(s) of evaluation of this end point: from time of operation until 12 weeks postoperative in case of reoperation until 24 weeks after the initial procedure	—

Countries

Austria, China

Contacts

Public ContactClinical Trials Information

Department of Neurosurgery, PMU

s.emich@salk.at004366244833601

Outcome results

None listed

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