To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients

NCT ID: NCT02064959

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-22
• Study Completion Date: 2019-02-07

Brief Summary

This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain normothermia.

The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow Outcome Scale-Extended (GOSE) at 6 months.

Conditions

Subdural Hematoma, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypothermia

Hypothermia to 33°C

Group Type: EXPERIMENTAL

Temperature management Zoll Intravascular Temperature Management device

Intervention Type: DEVICE

Normothermia

standard care - normothermia (37°C)

Group Type: ACTIVE_COMPARATOR

Temperature management Zoll Intravascular Temperature Management device

Intervention Type: DEVICE

Interventions

Temperature management Zoll Intravascular Temperature Management device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Non-penetrating traumatic brain injury
• Glasgow Coma Scale (GCS) motor score ≤5 (not following commands)
• Estimated or known age 22-65 years
• Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury
• Estimated time of injury to time to reach temp of 35°C<6 hrs

Exclusion Criteria

• Total GCS = 3 and bilateral fixed and dilated pupils
• Following commands after an initial period of coma (GSC motor score of 6)
• Known pre-existing neurological deficit (e.g., previous traumatic brain injury (TBI), stroke)
• Concomitant spinal cord injury
• Arrival temperature is <35°C
• Hemodynamic instability (i.e., mean arterial pressure (MAP)<60 millimetres of mercury (mmHg) for 30 minutes)
• Active cardiac dysrhythmia resulting in hemodynamic instability
• Pregnancy
• Duret hemorrhage
• Prisoner or Ward of the State
• Known history of clotting disorder (e.g., heparin induced thrombocytopenia, pulmonary embolism/deep venous thrombosis)
• 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 international normalized ratio (INR) >1.4)
• Inability to obtain informed consent or utilize exception to informed consent for emergency research.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Vivian L. Smith Center for Neurologic Research

OTHER

Sponsor Role: collaborator

Zoll Medical Corporation

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Dong Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong H. Kim, MD

Role: STUDY_CHAIR

The University of Texas Health Science Center, Houston

Locations

The University off Miami and Ryder Trauma Center, Jackson Memorial Hospital

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Cincinnati

Cincinnati, Ohio, United States

The University of Pittsburgh Medical Center and UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

The University of Texas at Houston Medical School and Memorial Hermann Hospital

Houston, Texas, United States

Kurume University Hospital

Fukuoka, , Japan

Saiseikai Fukuoka General Hospital

Fukuoka, , Japan

Kagawa University Hospital

Kagawa, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

Osaka Mishima Emergency Critical Care Center

Osaka, , Japan

National Disaster Medical Center

Tokyo, , Japan

Nippon Medical School Hospital

Tokyo, , Japan

Nippon Medical School Tamanagayama Hospital

Tokyo, , Japan

Yamaguchi University Hospital

Yamaguchi, , Japan

Countries

United States; Japan

References

Hergenroeder GW, Yokobori S, Choi HA, Schmitt K, Detry MA, Schmitt LH, McGlothlin A, Puccio AM, Jagid J, Kuroda Y, Nakamura Y, Suehiro E, Ahmad F, Viele K, Wilde EA, McCauley SR, Kitagawa RS, Temkin NR, Timmons SD, Diringer MN, Dash PK, Bullock R, Okonkwo DO, Berry DA, Kim DH. Hypothermia for Patients Requiring Evacuation of Subdural Hematoma: A Multicenter Randomized Clinical Trial. Neurocrit Care. 2022 Apr;36(2):560-572. doi: 10.1007/s12028-021-01334-w. Epub 2021 Sep 13.

Reference Type: DERIVED

PMID: 34518968 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-12-0762

Identifier Type: -

Identifier Source: org_study_id