NCT04686877

Brief Summary

This is a nationwide, multicenter, open-label, randomized controlled trial of early minimally invasive treatment for deep-seated spontaneous cerebral hemorrhage (dICH). The study consists of 2 steps: the first step is to conduct a dose climbing test to determine the safety and optimal dose of urokinase intra-hematoma irrigation after stereotactic aspiration; the second step is to validate whether stereotactic aspiration plus urokinase irrigation (the optimal dose determined in step one) is superior to conservative treatment in improving long-term outcomes (1 year) in early (within 24h) dICH patients.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 31, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

4.6 years

First QC Date

December 23, 2020

Last Update Submit

February 8, 2025

Conditions

Treatment of Spontaneous Intracerebral Hemorrhage

Keywords

Deep-Seated Spontaneous Intracerebral HemorrhageStereotactic AspirationUrokinase IrrigationRandomized Controlled TrialLong-term outcome

Outcome Measures

Primary Outcomes (1)

  • Good functional outcome, measured by the modified Rankin Scale (mRS)

    Good functional outcome is defined as a mRS of ≤3 points and will be assessed as binary outcome (yes/no, final value). In this context, a mRS score of 3 points reflects the ability to walk unassisted and care for one's own bodily needs despite being moderately dependent on assistance, while a mRS score of 4 points describes a patient who is not able to walk anymore and needs assistance with all daily activities and thus marks a severe loss of patient autonomy.

    At day 365 after randomization

Secondary Outcomes (3)

  • Proportion of hematoma evacuation by craniotomy or decompressive hemicraniectomy

    at 1 year after randomization

  • Residual hematoma volume

    At day 7 after randomization in the Conservative Treatment group; At 72 hours after the last urokinase infusion in the STAPLE group

  • All-cause mortality

    At 365 days after randomization

Study Arms (2)

STAPLE group

EXPERIMENTAL

In patients enrolled in the STAPLE group to receive the stereotactic CTA-guided aspiration and drainage, the surgery is performed within 36 h of symptoms onset. Urokinase injection is determined according to the CT scan 6 h after the surgery. Then the optimal dose of urokinase determined in Step A will be given. On the 1st, 3rd, 5th, and 7th day of post-operation, patients will be re-examined using CT. Conventional craniotomy and hematoma evacuation can be performed when cerebral hernia or rebleeding happened.

Procedure: STAPLE

Conservative treatment group

NO INTERVENTION

Patients in the conservative treatment group are treated routinely in accordance with Guidelines for the Management of Spontaneous Intracerebral Hemorrhage (AHA/ASA, 2015) 9. Hematoma evacuation by craniotomy or decompressive hemicraniectomy is considered in deteriorating patients as a life-saving measure.

Interventions

STAPLEPROCEDURE

Stereotactic aspiration plus urokinase clot irrigation

STAPLE group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 40 years or older;
  • the duration from onset to the baseline computed tomography angiography (CTA) scan was between 6 to 24 hours;
  • patients with a spontaneous ICH in the deep brain parenchyma (≥1 cm from the cortical surface); with hematoma volume more than 25 ml (measured with the ABC/2 method); without hydrocephalus caused by intraventricular hemorrhage; without cerebral herniation and the benefit of surgical treatment was unknown;
  • The Glasgow Coma Scale (GCS) ranged from 9 to 15;
  • patients with motor deficits;
  • The modified Rankin Score (mRS) ranged from 0 to1 before onset.

You may not qualify if:

  • ICH was caused by aneurysms, arteriovenous malformations, tumors, or trauma;
  • patients had a history of intracerebral hemorrhage or ischemic cerebral infarction;
  • patients had severe coagulation disorders with INR ≥ 1.5;
  • patients had severe underlying diseases, which may affect the outcomes;
  • pregnant and lactating patients;
  • patients refused to sign the informed consent and receive follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Related Publications (1)

  • Yan Z, Jiang L, Li G, Xia K, Peng L, Hu J, Chen S, Zhang J, Huang X. Efficacy study of neuronavigation-assisted stereotactic drilling of urokinase drainage versus craniotomy in the treatment of massive intracerebral haemorrhage in elderly patientsa. Sci Rep. 2024 Sep 3;14(1):20439. doi: 10.1038/s41598-024-71130-x.

    PMID: 39227662DERIVED

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Kang Dezhi, MD.

    The first affilicated hospital of Fujian Medical univercity

    STUDY CHAIR

Central Study Contacts

Lin Fuxin, PHD,MD

CONTACT

+86 13552358381lfxstuy@126.com

Kang Dezhi, MD

CONTACT

+86 13859099988kdz999888@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors assessed the outcome of patients on the basis of follow-up visits by telephone or in the clinic, with no knowledge of group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A surgical intervention model of stereotactic hematoma punctural catheter placement, drainage and urokinase irrigation in spontaneous intracerebral hemorrhage.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 29, 2020

Study Start

January 31, 2021

Primary Completion

August 31, 2025

Study Completion

September 30, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

We will share individual participant data after the primary results have been published.

Locations

CN(1)