NCT04647162

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

Safety of Surgical Treatment In Severe Primary Pontine Hemorrhage Evacuation (STIPE): a Multicentric, Randomized, Controlled, Open-label Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is being conducted from Jan 2022 to Nov 2024 in 20 neurosurgical units. This STIPE trial is an investigator-initiated, parallel (3:1 to surgical HE or MT), multi-centre, randomized controlled open-label trial following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will be conducted from Jan 2022 to Nov 2024 in 20 Tertiary hospitals in China. The flow chart of the clinical trial is presented in Figure 1. Neurosurgeons involved in the study are senior investigators with good clinical experience in sPPH management. Moreover, all investigators are well trained centrally according to the requirements.

Conditions

• Cerebrovascular Disorders
• Pontine Hemorrhage
• Primary
• Surgery

Interventions

Type	Name	Description
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。

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2020-11-30
• Last updated: 2023-12-08

Locations

20 sites across 1 country: China