Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Central South University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
Not provided
Not provided
Not provided
Not provided
This study is a prospective, multi-centre, randomized,controlled trial to compare the efficacy of long-term mild hypothermia with normothermic intensive management in patients with poor-grade aneurysmal subarachnoid hemorrhage.
The primary hypothesis is that the induction of mild hypothermia (maintained at 32-35℃) for at least 5 days would improve the outcome of patients at six months post hemorrhage compared with normothermia.
Aneurysmal subarachnoid hemorrhage (aSAH), especially poor-grade aSAH, is a medical emergency with very high morbidity and mortality rates. SAH constitutes a major public health concern in developed and developing countries. There were several clinical trials of hypothermia for aSAH conducted, however, with conflicting results.
Hypothermia therapy treatment is currently used in our department and other large neurosurgical centers across China to decrease the intracranial pressure (ICP), mitigate some of the destructive processes, and improve the functional outcome of patients with poor-grade aSAH. When the decision was made, the patients would be placed in wrapped cooling blankets or intravascular cooling device after they were sedated, intubated and mechanically ventilated. The patients would receive continuous infusions of some drugs using an infusion pump to prevent shivering. Once the patient's rectal, nasopharyngeal or blood temperature reached 32ËšC, it was kept at approximately that temperature (32-35ËšC) 3 to 7 days. Then the patients were passively rewarmed to a temperature of 36 to 37ËšC at a rate no greater than 0.25ËšC/hour, by gradual adjustment of the blanket thermostat.
The present multi-center, randomized controlled trials is designed to investigate the efficacy and safety of long-term (3 days) mild hypothermia versus normothermia on the outcome of patients with poor-grade aSAH. The primary outcome is the neurological function assessed at 1,3, 6 months post injury with the Glasgow Outcome Score (GOS). Additionally, the following data will also be recorded and compared: the baseline data, Glasgow Coma Score,imaging examination (e.g. CT scan), intracranial pressure, laboratory tests (e.g. blood routine test, liver and kidney function, blood gas analysis, etc), the complications (e.g. pneumonia, significant bleeding) and so on.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mild hypothermia | Experimental | Device: Zoll 2000 and/or CureWrap 3500 cooling system,lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree. |
|
| northermia | Placebo Comparator | normal physical cooling methods,like ice bag, conditionally required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoll 2000 and/or CureWrap 3500 cooling system | Procedure | Device(Zoll 2000 and/or CureWrap 3500 cooling system),lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological function | The neurological function will be evaluated at 6 months after hemorrhage by 2 specialized investigators who are unaware of the patients' allocation according to five-category Glasgow Outcome Scale as follows: 1, death; 2, vegetative state - unable to interact with the environment; 3, severe disability - unable to live independently but able to follow commands; 4, moderate disability - capable of living independently but unable to return to work or school; and 5, good recovery - able to return to work or school. | 6 months after hemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial pressure | The effect of long-term hypothermia on ICP control will be determined. | Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, until the monitor is removed |
| Length of ICU stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Qu, MD,PhD | Contact | 86-10-83198633 | xinqu0213@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Wang, MD,PhD | Xuanwu Hospital,Capital Medical University, Beijing | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19050656 | Background | Seule MA, Muroi C, Mink S, Yonekawa Y, Keller E. Therapeutic hypothermia in patients with aneurysmal subarachnoid hemorrhage, refractory intracranial hypertension, or cerebral vasospasm. Neurosurgery. 2009 Jan;64(1):86-92; discussion 92-3. doi: 10.1227/01.NEU.0000336312.32773.A0. | |
| 33987279 | Derived | Qu X, Shang F, Zhao H, Qi M, Cheng W, Xu Y, Jiang L, Chen W, Wang N, Zhang H. Targeted temperature management at 33 degrees Celsius in patients with high-grade aneurysmal subarachnoid hemorrhage: a protocol for a multicenter randomized controlled study. Ann Transl Med. 2021 Apr;9(7):581. doi: 10.21037/atm-20-4719. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020300 | Intracranial Hemorrhages |
Not provided
Not provided
| Tang-Du Hospital |
| OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| The First Hospital of Jilin University | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Shanxi Cardiovascular Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Yantai Yuhuangding Hospital | OTHER |
| Beijing Tiantan Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The numbers of days in the ICU
| 6 months post hemorrhage |
| Length of hospital stay | The numbers of days in the hospital. | 6 months post hemorrhage |
| Frequency of complications | Frequency of complications during the the study such as pneumonia, coagulation disturbance,electrolyte disturbances, liver and kidney function abnormality will be recorded and compared between groups. | 6 months post hemorrhage |
| Mortality rate | The proportion of death will be determined | 6 months after hemorrhage |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |