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A Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage

NCT04647162 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-12-08

No results posted yet for this study

Summary

Primary pontine hemorrhage (PPH) is not common but is the most catastrophic subtype of intracerebral hemorrhage, with acute mortality between 30% and 60%. For severe PPH, defined as Glasgow Coma score (GCS) \<8 and hematoma volume≥5ml, the mortality rate is as high as 80-100%. Guidelines from the American Heart Association and European Stroke Organization do not make definite specifications. More than a century after Finkelnburg first explored the brainstem for hematoma, however, plenty of researches have shown surgery can save lives and improve the prognosis for selective patients and can be an effective and safe treatment. This study is proposed to validate the safety of surgical treatment in severe primary pontine hemorrhage.

Conditions

  • Cerebrovascular Disorders
  • Pontine Hemorrhage
  • Primary
  • Surgery

Interventions

PROCEDURE

hematoma evacuation by craniotomy

The intervention method of hematoma evacuation is under craniotomy.

PROCEDURE

hematoma evacuation by stereotactic puncture

The intervention method of hematoma evacuation is under stereotactic puncture.

PROCEDURE

hematoma evacuation by neuroendoscopy

The intervention method of hematoma evacuation is under neuroendoscopy.

OTHER

life support

The treatments in medical group includes life support, nutrition support, and rehabilitation therapy。

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Chao You, MD · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647162 on ClinicalTrials.gov