Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01357057
Status:
COMPLETED
Last Update Posted:
2011-12-29
First Post:
2011-05-16
Brief Title:
Admission Bio-clinical Score to Predict One-year Outcomes in Coiled Subarachnoid Hemorrhage SAH
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Biological Markers in Patients Presenting Aneurism Coiling for Subarachnoid Hemorrhage
Status:
COMPLETED
Status Verified Date:
2011-05
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:
ABCSAH
Brief Summary:
The goal of this observational study is to develop and validate a predictive score of 1-year outcomes in subarachnoid hemorrhage SAH patients receiving aneurism coiling
Using our database filled up prospectively the investigators plan to collect clinical biological and radiological admission characteristics of coiled SAH cases and their 1-year Rankin outcome score during 5 years 2003-2007 The investigators plan to confirm our score in a validation cohort from 2008 to 2009
Using our database filled up prospectively the investigators plan to collect clinical biological and radiological admission characteristics of coiled SAH cases and their 1-year Rankin outcome score during 5 years 2003-2007 The investigators plan to confirm our score in a validation cohort from 2008 to 2009
Detailed Description:
The investigators plan to screen all patients who were consecutively admitted from January 1 2003 to our neurosurgical intensive care unit after a clinical diagnosis of SAH confirmed by cerebral angiography and treated with a coiling procedure Patients for whom a decision was made by the treating physician to either forego any invasive treatment or to perform open surgical clipping were excluded Clinical biological and radiological characteristics will be recorded during the course of hospitalization This observational study will be performed according to standard procedure
Admission characteristics At admission the investigators plan to anonymously record age sex GCS presence of motor deficit presence of clinical seizure and WFNS score The GCS refers to the value at admission before any treatment with sedative drugs The cohort was divided into two groups an admission coma group for patients with GCS13 WFNS 4 or 5 and a non-coma group for patients with GCS313 WFNS 1 to 3
Admission biological sampling of venous blood are routinely performed to measure S100beta and troponin per standard clinical practice in our ICU Troponin I and S100beta levels will be considered high for values higher than 05 mgL corresponding to 5 times the maximum normal range to be consistent with previous studies and to ensure high specificity
Admission radiological characteristics are obtained from the admission CT-scan and the initial angiogram The CT-scan will be reviewed by a neuro-radiologist and classified according to the modified Fisher score Hydrocephalus and intraventricular hemorrhage at admission were also registered Aneurysm site and number of aneurysms were obtained from the initial angiogram
ICU Management The ICU management will not be modified for this study Briefly a central venous line and an arterial catheter are routinely inserted at admission before coiling An external ventricular drain EVD is inserted in patients with CT evidence of hydrocephalus WFNS grade between III to V or a transcranial Doppler pulsatility index greater than 12 suggestive of increased intracranial pressure The EVD is routinely connected to an external pressure strain gauge to monitor ICP according to a recently published protocol
After coiling systolic arterial blood pressure is maintained between 130 and 150 mm Hg by a titration of IV norepinephrine ICP elevation higher than 20 mm Hg is treated by cerebra-spinal fluid drainage increased minute volume by mechanical ventilation when not already implemented deepening of sedation and rarely moderate hypothermia target core temperature between 355 to 365C An additional CT was performed whenever the clinical status deteriorated Acetaminophen and insulin are used as needed to avoid hyperthermia and hyperglycemia respectively For ventilated patients arterial carbon dioxide partial pressure PaCO2 was maintained between 35 and 40 mm Hg and peripheral oxygen saturation SPO2 above 97 when deemed possible Oral or enteral nutrition was started as soon as possible All patients received seizure prophylaxis from admission
Cerebral Vasospasm management strategy The investigators used our standard strategy for cerebral vasospasm management To summarize all patients receive IV nimodipine at 2 mghr from admission until the end of the second week after admission except during periods of uncontrolled hypoxia and ICP elevation Patients are switched to oral nimodipine 60 mg orally every 4 hrs at the time of ICU discharge to the ward for a total treatment period of 21 days The neurologic and hemodynamic status are assessed at least every 4 hours TCD was performed at least once a day during the first 10 days In unsedated patients in the event of clinical deterioration new symptoms uncontrolled cephalalgia confusion seizure motor deficit mean TCD velocities above 120 cms or a greater than 50 cms change in mean TCD velocity ref or after an increase in S100 cerebral angiogram was performed As is standard practice cerebral angiogram was performed after CT-scan ruled out other complications In sedated patients since clinical symptoms are not able to be assessed only the TCD and S100 criteria were used to evaluate the need for cerebral angiogram Each vasospasm episode is treated by intra-arterial nimodipine administration followed by intra-arterial milrinone 2 mg if necessary ref and repeated each day if necessary Mechanical angioplasty is used as second-line treatment when necessary Additionally hypertensive therapy is reinforced with a target SBP between 160 and 180 mm Hg Occurrences of vasospasm and of ischemic vasospasm neurological symptoms directly linked to artery spasm were recorded
Clinical Outcome The primary outcome is systematically assessed using the Rankin outcome scale at ICU-discharge and then 6 months and 1 year later The GCS WFNS and the Fisher scores will be compared to our new score for the prediction of 1-year mortality and 1-year full recovery defined as Rankin 0 to 1
Statistical Analysis To identify factors that independently predicted 1-year mortality multivariable analysis will be performed using backward stepwise logistic regression to enter variables that yielded p 005 in the univariate analyses The investigators will use an approximation of the odds ratio from the significant values of the stepwise logistic regression to construct a new score
The investigators will construct receiver operating characteristic ROC curves of this score and compared the areas under the ROC curves AUC of the ABC the WFNS the GCS and the Fisher score to predict 1-year mortality and 1-year full recovery defined as Rankin score 0-1 Statistical analyses will be performed using STATA version 11 StataCorp Texas USA
Admission characteristics At admission the investigators plan to anonymously record age sex GCS presence of motor deficit presence of clinical seizure and WFNS score The GCS refers to the value at admission before any treatment with sedative drugs The cohort was divided into two groups an admission coma group for patients with GCS13 WFNS 4 or 5 and a non-coma group for patients with GCS313 WFNS 1 to 3
Admission biological sampling of venous blood are routinely performed to measure S100beta and troponin per standard clinical practice in our ICU Troponin I and S100beta levels will be considered high for values higher than 05 mgL corresponding to 5 times the maximum normal range to be consistent with previous studies and to ensure high specificity
Admission radiological characteristics are obtained from the admission CT-scan and the initial angiogram The CT-scan will be reviewed by a neuro-radiologist and classified according to the modified Fisher score Hydrocephalus and intraventricular hemorrhage at admission were also registered Aneurysm site and number of aneurysms were obtained from the initial angiogram
ICU Management The ICU management will not be modified for this study Briefly a central venous line and an arterial catheter are routinely inserted at admission before coiling An external ventricular drain EVD is inserted in patients with CT evidence of hydrocephalus WFNS grade between III to V or a transcranial Doppler pulsatility index greater than 12 suggestive of increased intracranial pressure The EVD is routinely connected to an external pressure strain gauge to monitor ICP according to a recently published protocol
After coiling systolic arterial blood pressure is maintained between 130 and 150 mm Hg by a titration of IV norepinephrine ICP elevation higher than 20 mm Hg is treated by cerebra-spinal fluid drainage increased minute volume by mechanical ventilation when not already implemented deepening of sedation and rarely moderate hypothermia target core temperature between 355 to 365C An additional CT was performed whenever the clinical status deteriorated Acetaminophen and insulin are used as needed to avoid hyperthermia and hyperglycemia respectively For ventilated patients arterial carbon dioxide partial pressure PaCO2 was maintained between 35 and 40 mm Hg and peripheral oxygen saturation SPO2 above 97 when deemed possible Oral or enteral nutrition was started as soon as possible All patients received seizure prophylaxis from admission
Cerebral Vasospasm management strategy The investigators used our standard strategy for cerebral vasospasm management To summarize all patients receive IV nimodipine at 2 mghr from admission until the end of the second week after admission except during periods of uncontrolled hypoxia and ICP elevation Patients are switched to oral nimodipine 60 mg orally every 4 hrs at the time of ICU discharge to the ward for a total treatment period of 21 days The neurologic and hemodynamic status are assessed at least every 4 hours TCD was performed at least once a day during the first 10 days In unsedated patients in the event of clinical deterioration new symptoms uncontrolled cephalalgia confusion seizure motor deficit mean TCD velocities above 120 cms or a greater than 50 cms change in mean TCD velocity ref or after an increase in S100 cerebral angiogram was performed As is standard practice cerebral angiogram was performed after CT-scan ruled out other complications In sedated patients since clinical symptoms are not able to be assessed only the TCD and S100 criteria were used to evaluate the need for cerebral angiogram Each vasospasm episode is treated by intra-arterial nimodipine administration followed by intra-arterial milrinone 2 mg if necessary ref and repeated each day if necessary Mechanical angioplasty is used as second-line treatment when necessary Additionally hypertensive therapy is reinforced with a target SBP between 160 and 180 mm Hg Occurrences of vasospasm and of ischemic vasospasm neurological symptoms directly linked to artery spasm were recorded
Clinical Outcome The primary outcome is systematically assessed using the Rankin outcome scale at ICU-discharge and then 6 months and 1 year later The GCS WFNS and the Fisher scores will be compared to our new score for the prediction of 1-year mortality and 1-year full recovery defined as Rankin 0 to 1
Statistical Analysis To identify factors that independently predicted 1-year mortality multivariable analysis will be performed using backward stepwise logistic regression to enter variables that yielded p 005 in the univariate analyses The investigators will use an approximation of the odds ratio from the significant values of the stepwise logistic regression to construct a new score
The investigators will construct receiver operating characteristic ROC curves of this score and compared the areas under the ROC curves AUC of the ABC the WFNS the GCS and the Fisher score to predict 1-year mortality and 1-year full recovery defined as Rankin score 0-1 Statistical analyses will be performed using STATA version 11 StataCorp Texas USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None