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NCT Number: NCT04203550

The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH)

FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, Finland

About this study

FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR). In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The study will be conducted in all five neurosurgical departments in Finland. To determine whether operation without irrigation results in non-inferior outcome to operation with irrigation, we will randomize 426 patients into two groups and follow them up for 6 months using recurrence rates as the primary outcome. Secondary outcomes in our study include mortality, neurological outcome and complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation

o Predominantly hypodense or isodense on imaging (CT/MRI).

  • Clinical symptoms correlating with the CSDH
  • Patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant

Exclusion criteria

  • CSDH requiring surgical treatment other that burr-hole evacuation (e.g. craniotomy)
  • CSDH in a patient who has a cerebrospinal fluid shunt
  • Patients who have undergone any intracranial surgery before
  • Comatose patients (GCS 8 or lower) with absent motor responses to painful stimuli; decerebrate or decorticate posturing
  • Patient's postoperative cooperation is suspected to be insufficient for drain usage, i.e. disoriented or semiconscious patient
  • Patient has a hematogenic malignancy that has obtained active treatment within the previous five years
  • Patient has a central nervous system tumor or malignancy
  • Patient has acute infection with fever and requires antibiotic treatment at the moment
  • Patient has a high risk of life-threatening thrombosis (e.g. recent coronary stent, recent pulmonary embolism, low cardiac valve replacement) and discontinuation of antithrombotic medication is not recommended

Treatment and study plan

Intraoperative irrigation

Procedure

Operation with irrigation

No irrigation

Procedure

Operation without irrigation

Primary outcomes

  1. Rate of re-operations of ipsilateral chronic subdural hematoma

    Time frame: From operation up to 6 months after postoperatively

    Rate of reoperations between groups

Secondary outcomes

  1. Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation

    Time frame: At baseline, and at 2 and 6 months after operation

    Modified Rankin scale ranges from 1 to 6, where 1 indicates normal daily functionality and 6 indicates death

  2. Rate of mortality between intervention groups

    Time frame: From operation up to 6 months postoperatively

    Rate of mortality between intervention groups

  3. Duration of the operation between groups

    Time frame: Intraoperative measure

    Time (minutes) used to complete the operation, from incision to last suture

  4. Hospital length of stay between groups

    Time frame: From operation up to six months

    The duration of the stay in hospital (days)

  5. Change in the volume of CSDH in the CT or MRI image between baseline and 2 months post-operatively

    Time frame: Immediate preoperative and 2 months postoperatively

    The volume of CSDH will be measured from preoperative CT or MRI and at 2 months after operation CT or MRI

  6. Rate of complications and adverse events within 6 months

    Time frame: within 6 months after operation

    Rate of complication rate between groups

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Kuopio University Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • Turku University Hospital

Registry information

Official study title

The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH): a Study Protocol for a Multicenter Randomized Controlled Trial

Acronym: FINISH

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 18, 2019
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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