Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-05 @ 9:36 AM
Study NCT ID:
NCT03754335
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2018-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture
Status:
COMPLETED
Status Verified Date:
2023-02
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:
SAH-HELP
Brief Summary:
Headache control is one of the major challenges in patients who suffered an acute aneurysmal subarachnoid hemorrhage (aSAH). Headache affects 90% of the patient and is resistant to the major pain medication. It results from the increased intracranial pressure and the inflammation caused by the accumulation of arterial blood in the subarachnoid space. Hemorrhagic cerebrospinal fluid (CSF) removal by a lumbar puncture (LP), is well tolerated, reduces intracranial pressure and accelerates the clearance of the blood products from CSF. Nonetheless it has never been tested in a randomized trial. The investigators aim to compare in patients who experienced a low grade aSAH, the variation of headache intensity after CSF removal by LP vs. Sham LP in addition to predefined analgesic protocol management.
Detailed Description:
After aneurysmal subarachnoid hemorrhage (aSAH) almost 90 % of patients experience a severe headache during their hospital stay. Pain control often requires high doses of opioid drugs and sedation that remain only partially efficacious. In addition, there is to the investigator's knowledge currently no recommendation or consensus on aSAH related headache management. aSAH related headache results from the prolonged increased intracranial pressure and meningeal inflammation related to the accumulation of blood products in the subarachnoid space. Preliminary studies, suggest that hemorrhagic cerebrospinal fluid (CSF) removal by lumbar puncture (LP) or lumbar drain, is safe and decreases intracranial pressure. However its impact on headache control has never been tested. A reliable headache evaluation has to be performed among conscious patients experiencing a "low-grade" aSAH.
The objective of the study is to evaluate in patients experiencing low-grade acute aSAH (WFNS 1-3), the efficacy of CSF removal by LP vs. sham LP, on headache control. 74 patients with secured aneurysm by coiling, will be randomized (1:1) between day 3 and day 5 after aneurysmal rupture. The procedure will be performed in addition to a pre-specified antalgic protocol.
Mean headache intensity will be measured with the numeric verbal scale during the 24 hours before and the 24 hours after the procedure. The variation of mean intensity will be compared between the 2 groups.
The investigators hypothesize that this treatment may significantly decrease headache intensity after an aSAH. If this hypothesis is confirmed CSF removal by LP could be a simple cost effective and worldwide available strategy to improve
The objective of the study is to evaluate in patients experiencing low-grade acute aSAH (WFNS 1-3), the efficacy of CSF removal by LP vs. sham LP, on headache control. 74 patients with secured aneurysm by coiling, will be randomized (1:1) between day 3 and day 5 after aneurysmal rupture. The procedure will be performed in addition to a pre-specified antalgic protocol.
Mean headache intensity will be measured with the numeric verbal scale during the 24 hours before and the 24 hours after the procedure. The variation of mean intensity will be compared between the 2 groups.
The investigators hypothesize that this treatment may significantly decrease headache intensity after an aSAH. If this hypothesis is confirmed CSF removal by LP could be a simple cost effective and worldwide available strategy to improve
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-A00629-46 | OTHER | ID-RCB | View |