| CTRI Number |
CTRI/2022/11/047665 [Registered on: 25/11/2022] Trial Registered Prospectively |
| Last Modified On: |
04/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Intrathecal clot lysis trial to reduce vasospasm in aneurysmal subarachnoid hemorrhage for better outcomes.
|
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Scientific Title of Study
|
Randomized placebo-controlled trial of intrathecal clot lysis to reduce vasospasm in aneurysmal subarachnoid hemorrhage
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirudh Gupta |
| Designation |
Senior Resident,Neurosurgery |
| Affiliation |
jawaharlal institute of postgraduate medical education and research(JIPMER) |
| Address |
Department of Neurosurgery
On the second floor, Super Specialty Block (SSB)
Jawaharlal Institute of Post-graduate Medical Education & Research (JIPMER)
Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
08054099499 |
| Fax |
|
| Email |
guptaanirudh123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopalakrishnan Madhavan Sasidharan |
| Designation |
Professor,Neurosurgery |
| Affiliation |
jawaharlal institute of postgraduate medical education and research(JIPMER) |
| Address |
Department of Neurosurgery
On the second floor, Super Specialty Block (SSB)
Jawaharlal Institute of Post-graduate Medical Education & Research (JIPMER)
Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9345141431 |
| Fax |
|
| Email |
gopalakrishnanms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anirudh Gupta |
| Designation |
Senior Resident,Neurosurgery |
| Affiliation |
jawaharlal institute of postgraduate medical education and research(JIPMER) |
| Address |
Department of Neurosurgery
On the second floor, Super Specialty Block (SSB)
Jawaharlal Institute of Post-graduate Medical Education & Research (JIPMER)
Puducherry 605006
Pondicherry
PONDICHERRY
605008
India |
| Phone |
08054099499 |
| Fax |
|
| Email |
guptaanirudh123@gmail.com |
|
|
Source of Monetary or Material Support
|
| institutional support(JIPMER) |
|
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Primary Sponsor
|
| Name |
JIPMER PUDUCHERRY |
| Address |
JIPMER dhanvantri nagar puducherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anirudh Gupta |
Jawaharlal Institute of Post-graduate Medical Education and Research |
Department of Neurosurgery
On the second floor, Super Specialty Block (SSB)
Jawaharlal Institute of Post-graduate Medical Education & Research (JIPMER)
Puducherry 605006
Pondicherry
PONDICHERRY |
08054099499
guptaanirudh123@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G973||Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
urokinase, recombinant tissue plasminogen activator or tenecteplase
|
100 IU of tenecteplase, 50,000 IU of urokinase, or 1 mg of rtPA will be diluted upto 10ml and will be injected via an intracisternal, intrathecal catheter during microsurgical clipping of the aneurysm. The surgeon may choose to wash the subarachnoid cisterns with saline or Ringer’s lactate to wash out the lysed clots after waiting for 15 minutes though it is not mandatory to do so. The treating team can also consider repeating the injection of the drug through any route, a second time, if it considers it necessary after 24 hours (plus or minus 12 hours) of the previous dose. The treating team could take this decision if it feels that more clot removal could be attempted after seeing the residual clots on the CT scan. If the drug is injected after surgery through an indwelling catheter, the volume of the vehicle should not exceed 2 ml and it will be hand injected slowly over a minute to prevent any significant rise of intracranial pressure. If a larger volume has to be injected, like 10 ml, then it has to be injected using an automatic syringe pump at the rate of 0.5 ml per minute, if possible (if catheter is patent) by removing five to ten ml CSF initially. The tubing will be kept closed for at least two hours
|
| Comparator Agent |
normal saline |
10ml of normal saline will be used as placebo via the same route of administration and same protocol will be followed as per the intervention agent |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed with subarachnoid hemorrhage due to an aneurysmal rupture diagnosed with appropriate imaging methods like CT scan, CT angiography, MRI, MR angiography, and Digital Subtraction Angiography (DSA) and who have undergone treatment of the ruptured aneurysm, typically by microsurgical clipping or coiling.
|
|
| ExclusionCriteria |
| Details |
Remote subarachnoid hemorrhage (more than 14 days of aneurysmal rupture) where either the vasospasm has already set in or is likely to have disappeared.
Patients who have already developed severe vasospasm (Mean velocities of the MCA of 200 cm/sec or greater indicate severe spasm and correlate with 50% or greater narrowing on angiogram) detected by any imaging method or have already suffered delayed neurological deficits.
Patients in whom the ruptured aneurysm could not be fully secured by microsurgical clipping or endovascular coiling.
Spontaneously thrombosed aneurysms will also be excluded.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see if intrathecal clot lysis by instilling a thrombolytic agent reduces the mortality in patients with aneurysmal subarachnoid hemorrhage compared to a placebo |
During hospital stay and at discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Glasgow Outcome Scale (GOS) by classifying death, persistent vegetative state, and severe disability as bad outcomes and moderate disability and low disability as a good outcomes at the time of discharge from the hospital.
|
at the time of discharge from the hospital.
|
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Subarachnoid hemorrhage due to spontaneous rupture of saccular aneurysms can cause focal or widespread intracranial vasospasm in a substantial number of patients. It is a major cause of delayed ischemic neurological deficits, morbidity, and mortality even after treating the aneurysm by microsurgical clipping or coiling. Although many drugs (nimodipine, papaverine, magnesium preparations, nitroprusside, etc) through multiple routes (oral, CSF, arterial) and balloon angioplasty have been tried to prevent or reverse vasospasm, the problem of delayed neurological ischemic neurological deterioration (DIND) remains. Thus, removing thick clots enveloping the vessels in the subarachnoid space by instilling a thrombolytic agent appears to be a promising method to reduce the chances of vasospasm and delayed neurological deficits.As there has been a limited research on this topic, this study has been designed with primary objective to evaluate if intracisternal clot lysis by instilling a thrombolytic agent reduces the mortality in patients with aneurysmal subarachnoid hemorrhage compared to a placebo. We will use any thrombolytic agent like urokinase, recombinant tissue plasminogen activator, tenecteplase that are commonly used and available in the institute. The preferred agent will be urokinase as it is cheap. This is a randomised double blinded placebo controlled trial and will be done at JIPMER Puducherry. Patients will be enrolled after taking written informed consent. Results will be thoroughly noted and statistically analysed. |