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HypOthermia for Patients requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial

HypOthermia for Patients requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial - HOPES trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014863
Enrollment
120
Registered
2014-08-15
Start date
2015-04-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Acute Subdural Hematoma

Interventions

Preoperatively rapid-induced hypothermia therapy Normothermia

Sponsors

Department of Emergency and Critical Care Medicine Graduated School of Medicine, Nippon Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Non-penetrating traumatic brain injury 2. GCS motor score <= 5 (not following commands) 3. Estimated or known age 21-65 years 4. Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury

Exclusion criteria

Exclusion criteria: 1.Total GCS3 and bilateral fixed and dilated pupils 2.Following commands after an initial period of coma (GCS motor score of 6) 3.Known pre-existing neurological deficit (previous TBI, stroke) 4.Concomitant spinal cord injury 5.Arrival temperature is <35C 6.Hemodynamic instability (MAP<60mmHg for 30 minutes) 7.Active cardiac dysrhythmia resulting in hemodynamic instability 8.Pregnancy 9.Duret hemorrhage 10.Prisoner or Ward of the State 11.Known history of clotting disorder (heparin induced thrombocytopenia, PE/DVT) 12.Injury to other body organ where hypothermia would be precluded because of bleeding risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or INR>1.4) 13.Inability to obtain informed consent or utilize exception to informed consent for emer-gency research

Design outcomes

Primary

MeasureTime frame
Comparing the ratio of good and poor outcome based on 6-month Glasgow Coma Scale Extended(GOSE)

Countries

Japan,North America

Contacts

Public ContactShoji Yokobori

Graduated School of Medicine, Nippon Medical School Department of Emergency and Critical Care Medicine

shoji@nms.ac.jp03-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026