NCT06335641

Brief Summary

This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

July 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2025

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

March 21, 2024

Last Update Submit

December 24, 2024

Conditions

Stroke, Acute

Keywords

HypothermiaLarge vessel occlusionNeuroprotection

Outcome Measures

Primary Outcomes (1)

  • Adherence to the intervention

    Adherence is defined as undergoing active conductive head cooling for ≥50% of the time from first application of the cooling device

    From time of application in the emergency department until the end of the endovascular thrombectomy procedure

Study Arms (1)

Treatment arm

EXPERIMENTAL

Head cooling

Device: External active conductive head cooling

Interventions

External active conductive head coolingDEVICE

Cooling is applied during the endovascular thrombectomy procedure for a maximum of 120 minutes

Treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- All patients with anterior circulation acute ischemic stroke planned to undergo endovascular thrombectomy will be screened for recruitment.

You may not qualify if:

  • Admission core body temperature \<35°C.
  • Known contraindications to hypothermia, including hemodynamically unstable patients, new/symptomatic arrhythmia, hematological dyscrasias that affect thrombosis (cryoglobulinemia, sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thrombo-angiitis obliterans.
  • Skin lesions not allowing secure application of the cooling cap.
  • Unable to participate in follow-up at 3 months (e.g., resides outside of Alberta).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Te Whatu Ora Te Toka Tumai Auckland

Auckland, New Zealand

Location

MeSH Terms

Conditions

StrokeHypothermia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical fellow

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 28, 2024

Study Start

July 28, 2024

Primary Completion

November 24, 2024

Study Completion

February 24, 2025

Last Updated

December 30, 2024

Record last verified: 2024-12

Locations

NZ(1)CA(1)