Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301412
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-22
Brief Title:
Combination of Hypothermia and Thrombectomy in Acute Stroke
Sponsor:
University of Freiburg
Organization:
University of Freiburg
Study Overview
Official Title:
Combination of Targeted Temperature Management and Thrombectomy After Acute Ischemic Stroke COTTIS-2 - a Randomised Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COTTIS-2
Brief Summary:
The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion
The main question it aims to answer is does an additional cooling to 35C result in a benefit on clinical outcome Participants receive immediate cooling using a noninvasive transnasal cooling technique RhonoChill and are maintained at 35C for 6 hours after reopening of the vessel using surface cooling and then slowly rewarmed
Researchers will compare the intervention group hypothermia and endovascular treatment and best medical treatment including iv thrombolysis and control group only endovascular treatment and best medical treatment including iv thrombolysis to see if additional hypothermia leads to a better outcome after 3 months without relevant complications
The main question it aims to answer is does an additional cooling to 35C result in a benefit on clinical outcome Participants receive immediate cooling using a noninvasive transnasal cooling technique RhonoChill and are maintained at 35C for 6 hours after reopening of the vessel using surface cooling and then slowly rewarmed
Researchers will compare the intervention group hypothermia and endovascular treatment and best medical treatment including iv thrombolysis and control group only endovascular treatment and best medical treatment including iv thrombolysis to see if additional hypothermia leads to a better outcome after 3 months without relevant complications
Detailed Description:
Despite the well-established benefit of endovascular treatment EVT for acute ischemic stroke due to large vessel occlusion LVO more than half of patients treated with EVT remain functionally dependent despite high reperfusion rates Thus new strategies such as additional neuroprotection using hypothermia need to be explored first to bridge time to reperfusion and second to attenuate reperfusion injury
Although therapeutic hypothermia has consistently demonstrated robust neuroprotection in animal ischemic-reperfusion models randomized trials in acute stroke patients have failed to demonstrate the efficacy of induced hypothermia The reasons for this treatment failure are diverse and include treatment delay the unfeasibility of inducing and maintaining hypothermia due to intolerance and shivering in awake patients the missing recanalization in a large proportion of patients the heterogeneity of patients included and too deep 32-34C hypothermia associated with an increase in side effects
In the pilot study COTTIS-1 we could demonstrate the feasibility and safety of immediately induced intraischemic hypothermia to 35C with non-invasive transnasal cooling by RhinoChill BrainCool followed by surface cooling for 6h after recanalization in sedated and intubated patients with LVO undergoing EVT By combining this cooling technique with thrombectomy we have tried to address the above mentioned reasons for hypothermia failure In COTTIS-1 the target temperature of 35C was reached within 30 min corresponding to a cooling rate of 26Ch All patients reached the target temperature and 86 of the patients had reached 35C at recanalization by thrombectomy 68 of patients had a good outcome independency after 3 months There were only asymptomatic side effects during hypothermia
As a consequence the present COTTIS-2 study is planned to evaluate the efficiency of this cooling protocol in a multicentric randomized controlled end-point-blinded study in Germany
Although therapeutic hypothermia has consistently demonstrated robust neuroprotection in animal ischemic-reperfusion models randomized trials in acute stroke patients have failed to demonstrate the efficacy of induced hypothermia The reasons for this treatment failure are diverse and include treatment delay the unfeasibility of inducing and maintaining hypothermia due to intolerance and shivering in awake patients the missing recanalization in a large proportion of patients the heterogeneity of patients included and too deep 32-34C hypothermia associated with an increase in side effects
In the pilot study COTTIS-1 we could demonstrate the feasibility and safety of immediately induced intraischemic hypothermia to 35C with non-invasive transnasal cooling by RhinoChill BrainCool followed by surface cooling for 6h after recanalization in sedated and intubated patients with LVO undergoing EVT By combining this cooling technique with thrombectomy we have tried to address the above mentioned reasons for hypothermia failure In COTTIS-1 the target temperature of 35C was reached within 30 min corresponding to a cooling rate of 26Ch All patients reached the target temperature and 86 of the patients had reached 35C at recanalization by thrombectomy 68 of patients had a good outcome independency after 3 months There were only asymptomatic side effects during hypothermia
As a consequence the present COTTIS-2 study is planned to evaluate the efficiency of this cooling protocol in a multicentric randomized controlled end-point-blinded study in Germany
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None