Back to resultsHemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI) (HeMMI)
Primary Purpose
Infarction
Status
Terminated
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Hemicraniotomy
Standard medical treatment
Sponsored by
About this trial
This is an interventional prevention trial for Infarction focused on measuring Hemicraniectomy, stroke, decompressive surgery, HeMMI
Eligibility Criteria
Inclusion Criteria:
- Patients between 18 to 65 years old who presented with clinical signs of infarction of the MCA territory and who arrived at the hospital within 72 hours of symptom onset. Other inclusion criteria included a Glasgow coma score (GCS) of 6 to14 in patients with right MCA infarction or GCS 5 to 9 in patients with left MCA infarction (adjusted to account for effect on speech deficit on GCS scores), or GCS of 15 on arrival but subsequently deteriorated neurologically as defined by a score of ≥1 on the level of consciousness item of the National Institutes of Health Stroke Scale (NIHSS);computed tomography (CT) scan of the head showing ischemic changes corresponding to more than 50% of the MCA territory with or without involvement of other vascular territories;and written informed consent from the patient or a legal representative.
Exclusion Criteria:
- Patients with previous disabling neurological disease, an estimated premorbid modified Rankin Scale (mRS) score >2; terminal illness; presence of serious medical comorbidities like end-stage renal failure and cardiac disease with severe hemodynamic compromise; infarction due to surgical complications or vasospasm; primary intracranial hemorrhage; coagulopathies; and high risk for surgery upon assessment by the medical team.
Sites / Locations
- Philippine General Hospital - University of the Philippines Manila
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Medical Treatment Arm
Surgery with Medical Treatment Arm
Arm Description
Received standardized medical therapy in an intensive care unit (ICU), which included elevation of the head of bed at 30°, intermittent hyperventilation administered, and intravenous mannitol. Mean arterial pressure was maintained above 90 mm Hg. Hemoglobin concentration was maintained at all times above 90 g/L. Hyperglycemia, hyperthermia and hypotension were avoided or corrected when present.
Aside from receiving standardized medical therapy, decompressive hemicraniectomy was performed by removing a large bone flap at least 12 cm in diameter and included parts of the frontal, temporal, parietal and occipital bones, with further craniectomy to the floor of the temporal fossa. The dura was opened widely and duraplasty was performed using periosteum and temporalis fascia. The bone flap was either stored in a subcutaneous pocket in the abdomen or placed in the bone bank. Cranioplasty was performed during a separate admission on an elective basis not earlier than 6 months from the initial surgery.
Outcomes
Primary Outcome Measures
Functional status measured by modified Rankin Score (mRS)
The primary outcome measure was functional status measured by the modified Rankin Score, dichotomized as a good status (mRS 0-3) or poor status (mRS 4-6). A score of mRS 0-3 indicates functional status ranging from no symptoms to "moderate disability" (defined in the modified Rankin Scale as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from "moderately severe disability" (unable to walk or to attend to own bodily needs without assistance) through to death. A cut off of mRS 3 was adopted a priori because the ability to walk independently, with or without the help of a device, was considered a favorable outcome. Follow-up assessments, including mRS, were at seven days, two weeks, one month, three months, and six months post-stroke.
Secondary Outcome Measures
Survival measured by modified Rankin Score (mRS)
The Secondary outcome measure is the survival of the patients at six months measured using mRS scores dichotomized at mRS 0-4 and mRS 5-6 at six months. A score of mRS 0-4 indicates functional status ranging from no symptoms to "moderately severe disability" (unable to walk without assistance and unable to attend to own bodily needs without assistance); mRS 5-6 indicates functional status ranging from "severe disability" (bedridden, incontinent and requiring constant nursing care and attention) through to death. The latter outcome was considered because it was included in previous trial reports
Full Information
NCT ID
NCT02002234
First Posted
November 7, 2013
Last Updated
April 16, 2020
Sponsor
University of the Philippines
1. Study Identification
Unique Protocol Identification Number
NCT02002234
Brief Title
Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI)
Acronym
HeMMI
Official Title
Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI): A Single Center Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Recruitment for the study was terminated due to slow recruitment
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Philippines
4. Oversight
5. Study Description
Brief Summary
A single-centered, randomized, controlled clinical trial comparing standardized medical care alone with standardized medical care and decompressive hemicraniectomy to determine the effectiveness of decompressive surgery more definitively in patients with clinical signs of infarction of the Middle Carotid Artery (MCA) territory.
Detailed Description
A single-centered, randomized, controlled clinical trial comparing standardized medical care alone with standardized medical care and decompressive hemicraniectomy to determine the effectiveness of decompressive surgery more definitively in patients with clinical signs of infarction of the MCA territory and and who arrived at the hospital within 72 hours of symptom onset.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infarction
Keywords
Hemicraniectomy, stroke, decompressive surgery, HeMMI
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical Treatment Arm
Arm Type
Other
Arm Description
Received standardized medical therapy in an intensive care unit (ICU), which included elevation of the head of bed at 30°, intermittent hyperventilation administered, and intravenous mannitol. Mean arterial pressure was maintained above 90 mm Hg. Hemoglobin concentration was maintained at all times above 90 g/L. Hyperglycemia, hyperthermia and hypotension were avoided or corrected when present.
Arm Title
Surgery with Medical Treatment Arm
Arm Type
Other
Arm Description
Aside from receiving standardized medical therapy, decompressive hemicraniectomy was performed by removing a large bone flap at least 12 cm in diameter and included parts of the frontal, temporal, parietal and occipital bones, with further craniectomy to the floor of the temporal fossa. The dura was opened widely and duraplasty was performed using periosteum and temporalis fascia. The bone flap was either stored in a subcutaneous pocket in the abdomen or placed in the bone bank. Cranioplasty was performed during a separate admission on an elective basis not earlier than 6 months from the initial surgery.
Intervention Type
Procedure
Intervention Name(s)
Hemicraniotomy
Intervention Description
Hemicraniotomy involves removing a large bone flap at least 12 cm in diameter and included parts of the frontal, temporal, parietal and occipital bones, with further craniectomy to the floor of the temporal fossa. The dura was opened widely and duraplasty was performed using periosteum and temporalis fascia. The bone flap was either stored in a subcutaneous pocket in the abdomen or placed in the bone bank.
Intervention Type
Procedure
Intervention Name(s)
Standard medical treatment
Intervention Description
Standard medical treatment involves elevation of the head of bed at 30°, intermittent hyperventilation administered, and intravenous mannitol. Mean arterial pressure was maintained above 90 mm Hg. Hemoglobin concentration was maintained at all times above 90 g/L.
Primary Outcome Measure Information:
Title
Functional status measured by modified Rankin Score (mRS)
Description
The primary outcome measure was functional status measured by the modified Rankin Score, dichotomized as a good status (mRS 0-3) or poor status (mRS 4-6). A score of mRS 0-3 indicates functional status ranging from no symptoms to "moderate disability" (defined in the modified Rankin Scale as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from "moderately severe disability" (unable to walk or to attend to own bodily needs without assistance) through to death. A cut off of mRS 3 was adopted a priori because the ability to walk independently, with or without the help of a device, was considered a favorable outcome. Follow-up assessments, including mRS, were at seven days, two weeks, one month, three months, and six months post-stroke.
Time Frame
up to six months
Secondary Outcome Measure Information:
Title
Survival measured by modified Rankin Score (mRS)
Description
The Secondary outcome measure is the survival of the patients at six months measured using mRS scores dichotomized at mRS 0-4 and mRS 5-6 at six months. A score of mRS 0-4 indicates functional status ranging from no symptoms to "moderately severe disability" (unable to walk without assistance and unable to attend to own bodily needs without assistance); mRS 5-6 indicates functional status ranging from "severe disability" (bedridden, incontinent and requiring constant nursing care and attention) through to death. The latter outcome was considered because it was included in previous trial reports
Time Frame
up to six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 18 to 65 years old who presented with clinical signs of infarction of the MCA territory and who arrived at the hospital within 72 hours of symptom onset. Other inclusion criteria included a Glasgow coma score (GCS) of 6 to14 in patients with right MCA infarction or GCS 5 to 9 in patients with left MCA infarction (adjusted to account for effect on speech deficit on GCS scores), or GCS of 15 on arrival but subsequently deteriorated neurologically as defined by a score of ≥1 on the level of consciousness item of the National Institutes of Health Stroke Scale (NIHSS);computed tomography (CT) scan of the head showing ischemic changes corresponding to more than 50% of the MCA territory with or without involvement of other vascular territories;and written informed consent from the patient or a legal representative.
Exclusion Criteria:
Patients with previous disabling neurological disease, an estimated premorbid modified Rankin Scale (mRS) score >2; terminal illness; presence of serious medical comorbidities like end-stage renal failure and cardiac disease with severe hemodynamic compromise; infarction due to surgical complications or vasospasm; primary intracranial hemorrhage; coagulopathies; and high risk for surgery upon assessment by the medical team.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annabelle E Chua, MD
Organizational Affiliation
University of the Philippines Manila
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philippine General Hospital - University of the Philippines Manila
City
Manila
State/Province
Metro Manila
ZIP/Postal Code
1000
Country
Philippines
12. IPD Sharing Statement
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Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI)
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