COmbination of Targeted temperature management and Thrombectomy after acute Ischemic Stroke (COTTIS) – a pilot feasibility and safety study

COmbination of Targeted temperature management and Thrombectomy after acute Ischemic Stroke (COTTIS) – a pilot feasibility and safety study - COTTIS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023573

Enrollment

Registered

2021-11-11

Start date

2021-12-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I63

Interventions

Group 1: Patient with intervention hypothermia treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) All patients with occlusion of proximal vessels in the anterior circulation during 24 h of stroke onset and indication for thrombectomy according to DGN/ ESO guidelines 2) age over 18 years old 3) patients are allowed to receive intravenous thrombolysis before thrombectomy 4) no severe disability before ischemic stroke (mRS = 1)

Exclusion criteria

Exclusion criteria: 1) Known coagulopathy, oral anticoagulants INR > 3,0 2) platelet count400mg/dl 4) persistently high blood pressure systolic > 220 mmHg or diastolic > 110 mmHg despite analgosedation and antihypertensive drugs 5) severe advanced disease, life expectancy 1) 11) Evidence of bleeding in cerebral CT or MRT (cerebral microbleeds due to hypertension or cerebral amyloid angiopathy are allowed)

Design outcomes

Primary

Measure	Time frame
Time since reaching target temperature (35 °C, measured esophageally)	—

Secondary

Measure	Time frame
1) infarct volume in standard CT imaging 24 hours after thrombectomy 2) modification / increase of infarct core in CT imaging comparing hospital admission and after 24 hours 3) result of recanalisation after thrombectomy (TICI-Score, based on angiography during / after thrombectomy) and after 24 hours (based on ultrasound of the brain-supplying vessels) 4) NIHSS during hospital admission process, date of leaving the hospital/transfer to rehabilition) 5) mRS at date of leaving the hospital/transfer to rehabilition and after 3 months (regular meeting at stroke-aftercare-ambulance at Freiburg or by telephone if desired) 6) proportion of patients with excellent clinical outcome after 3 months (mRS 0-1) 7) mortality during acute inpatient care and after 3 months 8) temperature profile at different measurement spots (esophageal, tympan, bladder, forehead)	—

Measure

Time frame

1) infarct volume in standard CT imaging 24 hours after thrombectomy 2) modification / increase of infarct core in CT imaging comparing hospital admission and after 24 hours 3) result of recanalisation after thrombectomy (TICI-Score, based on angiography during / after thrombectomy) and after 24 hours (based on ultrasound of the brain-supplying vessels) 4) NIHSS during hospital admission process, date of leaving the hospital/transfer to rehabilition) 5) mRS at date of leaving the hospital/transfer to rehabilition and after 3 months (regular meeting at stroke-aftercare-ambulance at Freiburg or by telephone if desired) 6) proportion of patients with excellent clinical outcome after 3 months (mRS 0-1) 7) mortality during acute inpatient care and after 3 months 8) temperature profile at different measurement spots (esophageal, tympan, bladder, forehead)

—

Countries

Germany

Contacts

Public ContactJürgen Bardutzky

Neurozentrum, Universitätsklinikum Freiburg

juergen.bardutzky@uniklinik-freiburg.de0761 270 53090

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026