A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma

NCT06621407 | Recruiting DMC

• 1 other identifier: N-20240009
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 4

Brief Summary

Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking. The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH. The study is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark. Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities, and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides. Before surgical hematoma evacuation patients will be randomized to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage. The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence. Secondary outcomes are 90-day simplified modified Rankin score (smRSq), and complications related to surgery or occurring during admission, including intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal hematoma, thromboembolic events, infections and seizures. Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years. Ethics approval for inclusion of competent patients has been obtained (N-20240009).

Conditions

Chronic Subdural Hematoma; Surgical Procedures, Operative; Recurrence; Mortality; Drainage; Drainage/Methods; Drainage Procedure

Outcome Measures

Primary Outcomes (1)

• Composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period

  The primary outcome measure is a composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period. Recurrent CSDH is defined as a re-accumulation of the previously treated CSDH requiring ipsilateral or bilateral reoperation following symptom improvement after the first operation. For both unilateral and bilateral hematomas, recurrence will be considered as one reoperation.

  From enrollment to 90-days postsurgery

Secondary Outcomes (9)

• 90-day simplified modified Rankin scale

  90 days after enrollment

• 90-day serious adverse events (SAE)

  From time of surgery to 90-days postoperative

• Complications related to surgery

  From enrollment to 90-days postsurgery

• Postoperative adverse events during the admission

  From enrollment to admission from hospital assessed up to 90-days postsurgery

• Length of hospitalization

  From enrollment to admission from neurosurgical department, and from surgical CSDH evacuation to discarge to home or nursing facility, assessed up to 90-days postsurgery

Other Outcomes (4)

• Use of antithrombotics

  From admission to 90-days postoperative

• Time to surgery

  From adimission to time of surgery

• Unilateral versus bilateral CSDH

  From admission to 90 days postoperative

Study Arms (2)

24 hours active subperiostal drainage

EXPERIMENTAL

24 hours active subperiostal drainage after single burr hole evacuation of a chronic subdural hematoma

Procedure: 24 hours active subperiostal drainage

24 hours passive subdural drainage

EXPERIMENTAL

24 hours passive subdural drainage after single burr hole evacuation of a chronic subdural hematoma

Procedure: 24 hours passive subdural drainage

Interventions

24 hours active subperiostal drainage PROCEDURE

24 hours active subperiostal drainage after single burr hole evacuation of a chronic subdural hematoma

24 hours active subperiostal drainage

24 hours passive subdural drainage PROCEDURE

24 hours passive subdural drainage after single burr hole evacuation of a chronic subdural hematoma

24 hours passive subdural drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 years).
• Patients with symptomatic CSDH confirmed on brain CT- or magnetic resonance imaging (MRI), admitted to a Danish neurosurgical department for surgical treatment.
• Patients undergoing a single burr-hole evacuation.
• Informed written and oral consent is taken prior to surgery.

You may not qualify if:

• Patients who are mentally incapacitated
• Patients with known abnormalities in their cerebrospinal fluid (protein and glucose levels, cell count, and type)
• Patients with changes or abnormalities in their normal cerebrospinal fluid dynamics, e.g., obstructive hydrocephalus, normal pressure hydrocephalus, intracranial hypotension, and ventricular peritoneal shunt.
• Patients with additional/previously intracranial pathology that requires/has required neurosurgical treatment (e.g., brain tumor, vascular malformation, abscess).
• Patients with recurrent CSDH or with previous craniotomy or other transcranial surgery (for any reason)
• Patients unable to give consent prior to surgery

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Odense University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Aarhus University Hospital: collaborator

Study Sites (4)

Department of Neurosurgery, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Department of Neurosurgery, Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Department of Neurosurgery, Odense University Hospital

Odense, 5100, Denmark

RECRUITING

Related Publications (2)

• Hjortdal Gronhoj M, Jensen TSR, Miscov R, Sindby AK, Debrabant B, Hundsholt T, Bjarkam CR, Bergholt B, Fugleholm K, Poulsen FR; DACSUHS group. Optimal drainage time after evacuation of chronic subdural haematoma (DRAIN TIME 2): a multicentre, randomised, multiarm and multistage non-inferiority trial in Denmark. Lancet Neurol. 2024 Aug;23(8):787-796. doi: 10.1016/S1474-4422(24)00175-3. Epub 2024 Jun 12.

  PMID: 38878790 BACKGROUND

• Terkelsen JH, Miscov R, Jensen TSR, Schack A, Gronhoj MH, Korshoj AR, Haldrup M, Poulsen FR, Fugleholm K, Bjarkam CR, Olsen MH. Active subperiosteal vs. passive subdural 24-h drainage following single burr hole evacuation of chronic subdural hematoma: statistical analysis plan for the multicenter, randomized, non-inferiority clinical trial SUPERDURA. Trials. 2026 Jan 17. doi: 10.1186/s13063-026-09434-8. Online ahead of print.

  PMID: 41546119 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Recurrence

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Carsten R Bjarkam, MD, PhD, DMSc

  Department of Neurosurgery, Aalborg University Hospital, Denmark

  STUDY DIRECTOR

Central Study Contacts

Carsten R Bjarkam, Professor, Ph.D., DMSc.

CONTACT

45+ 211671; c.bjarkam@rn.dk

Rares Miscov, MD

CONTACT

45+ 27831360; ram@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the inherent nature of the intervention blinding of the treating personnel is not possible. However, patients, the study statisticians, the 90-day outcome assessors, and the study steering group will be blinded to the allocation. Furthermore, statistical analyses and initial interpretation of the results will be performed using data with blinded treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Consultant

Model Details: Randomized multicenter clinical non-inferiority trial encompassing all neurosurgical units in Denmark. All adult patients with symptomatic unilateral CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be considered for inclusion. Before surgical hematoma evacuation patients will be randomized to 24 hours passive subdural drainage or 24 hours active subperiostal drainage, and the drain placed accordingly at the end of the hematoma evacuation procedure. The primary end point is a composite outcome of 90-day mortality, and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day follow-up period.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 1, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From December 1st 2024 to November 30th 2032
• Access Criteria: A written request to gain access to the datasets obtained during this study can be sent to the corresponding author, which will be discussed in the DACHSUS research team. If approved, the corresponding author will be responsible for providing access to research data requested by third parties, unless access to the data is restricted by a legal obligation (e.g., non-disclosure agreement), intellectual property protection, ethical approval requirements, ethical or security reasons, or other legitimate reasons.

Locations

DK (4)