Trials / Terminated
TerminatedNCT02002234
Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI)
Hemicraniectomy for Malignant Middle Cerebral Artery Infarction (HeMMI): A Single Center Randomized Controlled Clinical Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- University of the Philippines · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2002-01-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2013-12-05
- Last updated
- 2020-04-20
Locations
1 site across 1 country: Philippines
Source: ClinicalTrials.gov record NCT02002234. Inclusion in this directory is not an endorsement.