Medical Cooling of Ice Hockey Players | NCT04701125

Studies
Medical Cooling of Ice Hockey Players

NCT04701125

Sponsor

Region Skane

Status

Completed

Last Update Posted

Jan 8, 2021Actual

Enrollment

81Actual

Phase

Not Applicable

Conditions

Sports-related Concussions, Selective Head-neck Cooling, Return to Play

Interventions

selective head-neck cooling using PolarCap system

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

Dec 28, 2020

First Submission Date that Met QC Criteria

Jan 7, 2021

First Posted Date

Jan 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2021

Last Update Posted Date

Jan 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The incidence of Sports-related concussions (SRCs) has risen in recent years, not least in ice hockey, and available treatment options are limited. Here, we addressed the hypotheses that immediate controlled head- and neck cooling could hasten return-to-play in a Swedish cohort of concussed professional ice hockey players. Over three seasons, 15 teams used either immediate head- and neck cooling or standard management for SRC. All players (81) followed the same return-to-play management protocol.

Detailed Description

Sports-related concussions (SRCs) are a growing health concern, since they may lead to persistent symptoms and, particularly if repeated, to e.g. depression, accelerated dementia onset, and development of chronic traumatic encephalopathy. Here, we addressed the hypotheses that immediate controlled head- and neck cooling could hasten return-to-play in a Swedish cohort of concussed professional ice hockey players. Over three seasons, 15 teams used either immediate head- and neck cooling or standard management for SRC. All players followed the same return-to-play management protocol. Using a baseline questionnaire, no difference in the number of previous SRCs between groups was observed. In total, 92 SRCs were recorded. Eleven players did not complete the study protocol, and thus 81 players were included. Of these, 29 were treated by immediate selective head- and neck cooling for ≥ 30 min, and 52 controls received standard acute SRC management.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Players receive selective head-neck cooling after concussion	Device: selective head-neck cooling using PolarCap system
control group	No Intervention	Players receive the standard sport-related concussion management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
selective head-neck cooling using PolarCap system	Device	Players receiving selective head-neck cooling after SRC	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
return-to-play	The primary endpoint of the study was time (in days) from concussion until returning to full practice or game	two weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elite ice hockey players diagnosed by a team physician to have suffered a sports-related concussion. Selective head-neck cooling following the concussion. Duration of cooling a minimum of 45 minutes.

Exclusion Criteria:

Presence of red flags (loss of consciousness, seizure, worsening headache, repeated vomiting, focal neurological deficits, neck pain, tingling in arms). Inability to tolerate cooling for a minimum of 30 minutes. Age <18 years old.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University		Lund		221 00	Sweden

Intervention Model Description

Twenty-eight teams from the elite ice hockey leagues for males in Sweden were invited to participate in the study. Participating teams were given the option to be in the study group (receiving selective head-neck cooling after SRC) or the control group (standard SRC management). Any player with a suspected or diagnosed concussion was immediately removed from practice or game participation for further evaluation. Concussion diagnosis was established using the concussion in the sports consensus statement. At the time of SRC, any presence of "red flags" mandated the player to be taken to the hospital. As soon as the diagnosis of SRC was established the player was included in the study and players in the intervention teams were treated by selective head-neck cooling system for a minimum of 30 minutes. The primary endpoint of the study was the time (in days) from concussion until returning to full practice or game.