Trial record 18 of 36 for:    "cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy" OR "Cerebral Arterial Diseases"

Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI): A Single Center Randomized Controlled Clinical Trial

This study has been terminated.
(Recruitment for the study was terminated due to slow recruitment)
Sponsor:
Information provided by (Responsible Party):
University of the Philippines
ClinicalTrials.gov Identifier:
NCT02002234
First received: November 7, 2013
Last updated: February 16, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Infarction of the Middle Carotid Artery Territory.
Procedure: Hemicraniotomy
Procedure: Standard medical treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI): A Single Center Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of the Philippines:

Primary Outcome Measures:
  • Functional status measured by modified Rankin Score (mRS) [ Time Frame: up to six months ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: up to six months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 29
Study Start Date: January 2002
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Medical Treatment Arm
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.
Procedure: Standard medical treatment
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.
Surgery with Medical Treatment Arm
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.
Procedure: Hemicraniotomy
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002234

Locations
Philippines
Philippine General Hospital - University of the Philippines Manila
Manila, Metro Manila, Philippines, 1000
Sponsors and Collaborators
University of the Philippines
Investigators
Principal Investigator: Annabelle E Chua, Medical Doctor University of the Philippines Manila
  More Information

No publications provided

Responsible Party: University of the Philippines
ClinicalTrials.gov Identifier: NCT02002234     History of Changes
Other Study ID Numbers: RIDO 2002
Study First Received: November 7, 2013
Last Updated: February 16, 2014
Health Authority: Philippines: Research Implementation and Development Office Ethics Committee, College of Medicine, University of the Philippines Manila

Keywords provided by University of the Philippines:
Hemicraniectomy, stroke, decompressive surgery, HeMMI

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Infarction
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014