Trial of Long-term Therapeutic Hypothermia for Poor-grade Aneurysmal

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 32˚C, it was kept at approximately that temperature (32-35˚C) 3 to 7 days. Then the patients were passively rewarmed to a temperature of 36 to 37˚C at a rate no greater than 0.25˚C/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. ;

Study Design

Related Conditions & MeSH terms

Aneurysmal Subarachnoid Hemorrhage
Hemorrhage
Hypothermia
Subarachnoid Hemorrhage

Clinical Trial Details

NCT number	NCT03442608
Study type	Interventional
Source	Xuanwu Hospital, Beijing
Contact	Xin Qu, MD,PhD
Phone	86-10-83198633
Email	xinqu0213@126.com
Status	Not yet recruiting
Phase	N/A
Start date	March 1, 2018
Completion date	December 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05669313` - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Not yet recruiting	`NCT05306392` - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation	N/A
Completed	`NCT02685176` - Head and Torso Rewarming Using a Human Model for Severe Hypothermia	N/A
Withdrawn	`NCT02812069` - WarmSmart Warming Protocol	N/A
Completed	`NCT02586974` - Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response	N/A
Completed	`NCT02742818` - Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models	N/A
Completed	`NCT02121574` - Accuracy of Zero-flux and Ingestible Thermometers	N/A
Completed	`NCT02177903` - Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes	N/A
Not yet recruiting	`NCT02211703` - National Epidemiologic Survey on the Incidence of Perioperative Hypothermia	N/A
Recruiting	`NCT01866384` - Targeted Temperature Management After Intracerebral Hemorrhage	Phase 2
Active, not recruiting	`NCT01529658` - Renal Hypothermia During Partial Nephrectomy	N/A
Completed	`NCT01793337` - Core Body Temperature Measurement During Hot and Cold Environmental Exposure	N/A
Completed	`NCT01722955` - Pre-warmed Intravenous Fluids and Monitored Anesthesia Care	N/A
Completed	`NCT01559675` - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery	N/A
Terminated	`NCT01018576` - Delayed Cord Clamping in Premature Infants	N/A
Completed	`NCT00904228` - Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room	N/A
Terminated	`NCT00822796` - Thermogard™ Efficacy Trial	N/A
Completed	`NCT00334360` - Dexmed/Buspirone Synergism on Shivering	Phase 4
Not yet recruiting	`NCT06283771` - The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering	N/A
Completed	`NCT04399902` - Study to Actively Warm Trauma Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Trial of Long-term Therapeutic Hypothermia for Poor-grade Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms