Clinical Trials Logo
  1. Home
  2. Headache
  3. NCT03754335

SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture — SAH-HELP  

Headache Clinical Trial

Official title:
SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03754335
Study type Interventional
Source University Hospital, Toulouse
Contact
Status Completed
Phase N/A
Start date November 28, 2018
Completion date December 1, 2022
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT03472872 - A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache Phase 4
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Withdrawn NCT02866084 - Neuromodulation Treatment of Vestibular Migraines N/A
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Not yet recruiting NCT04352218 - Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache Phase 2
Completed NCT02734992 - Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers N/A
Completed NCT01327118 - Prostaglandin F2alpha in a Human Headache Model N/A
Completed NCT01153789 - Study of Oculomotor Dysfunction Leading to Children Vertigo N/A
Not yet recruiting NCT00969995 - Identification of Inflammatory Markers in Migraine Patients N/A
Not yet recruiting NCT00752921 - Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache Phase 4
Terminated NCT00291395 - PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers Phase 1
Completed NCT00212810 - Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache. Phase 4
Completed NCT00263094 - An End to the Yom Kippur (and Ramadan) Headache N/A
Completed NCT00135122 - Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache Phase 3
Completed NCT02475005 - An Intervention to Improve Adolescent Headache Self-management N/A
Completed NCT03163901 - The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury N/A
Completed NCT01664585 - Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life N/A
Completed NCT04632420 - Evaluation of Headache and Childbirth in a Chronic Pain Population
Recruiting NCT05033613 - Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease