The HATS-study: will a hat help patients with hypothermia to rewarm faster?

Hats As Temperature Support (HATS): A randomized controlled trial of a hat + standard of care versus standard of care in patients with hypothermia. - HATS - Hats As Temperature Support

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58064

Enrollment

106

Registered

2025-06-24

Start date

2025-11-29

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Hypothermia, low body temperature, Accidental or primary hypothermia, secondary hypothermia Low body temperature

Interventions

A hat

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Registered at the emergency departmentAge = 18 years Rectally measured temperature < 35 °C

Exclusion criteria

Exclusion criteria: Unable to provide verbal consent by patient or legal representative

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the time from randomization to normothermia, defined as a rectally measured core temperature of 35°C.	—

Secondary

Measure	Time frame
Secondary endpoints will be the length of stay on the emergency department, the need for intensive care unit admission, difference of the effect of a hat on time to normothermia in bald and non-bald patients, occurrence of the 'afterdrop' phenomenon, the incidence of hypotension, and the relations between rewarming speed and both hypotension and afterdrop. Afterdrop is defined as a drop (> 1 °C) in temperature after randomization.	—

Measure

Time frame

Secondary endpoints will be the length of stay on the emergency department, the need for intensive care unit admission, difference of the effect of a hat on time to normothermia in bald and non-bald patients, occurrence of the 'afterdrop' phenomenon, the incidence of hypotension, and the relations between rewarming speed and both hypotension and afterdrop. Afterdrop is defined as a drop (> 1 °C) in temperature after randomization.

—

Countries

Netherlands

Contacts

Public ContactC.L.M. Roij van Zuijdewijn

Spaarne Gasthuis

poliinternegeneeskunde@spaarnegasthuis.nl+31232240050

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026