NCT04686877 (STAPLE-dICH) is a NA clinical trial of STAPLE in Treatment of Spontaneous Intracerebral Hemorrhage, sponsored by First Affiliated Hospital of Fujian Medical University.

Who is sponsoring NCT04686877?

NCT04686877 is sponsored by First Affiliated Hospital of Fujian Medical University.

What drugs are being tested in NCT04686877?

Interventions in NCT04686877: STAPLE.

What condition does NCT04686877 study?

NCT04686877 studies Treatment of Spontaneous Intracerebral Hemorrhage.

Is NCT04686877 still recruiting?

NCT04686877 is currently recruiting now. Last updated 12 February 2025.

Last reviewed 2025-02-12 · How we verify

NCT04686877: STAPLE-dICH

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation

Recruiting now NA Last updated 12 February 2025

What this trial tests

NA trial testing STAPLE in Treatment of Spontaneous Intracerebral Hemorrhage in 400 participants. Currently enrolling.

Timeline

31 January 2021

Primary endpoint
31 August 2025

30 September 2025

Quick facts

Lead sponsor	First Affiliated Hospital of Fujian Medical University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	400
Start date	31 January 2021
Primary completion	31 August 2025
Estimated completion	30 September 2025
Sites	1 location across China

Drugs / interventions tested

STAPLE

Conditions studied

Treatment of Spontaneous Intracerebral Hemorrhage — all drugs for Treatment of Spontaneous Intracerebral Hemorrhage →

Sponsor

First Affiliated Hospital of Fujian Medical University

Who can join

40 and older, any sex, with Treatment of Spontaneous Intracerebral Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Surgery for spontaneous supratentorial intracerebral haemorrhage.
Wilting FN, Sondag L, Schreuder FH, Dammers R, et al · · 2025 · cited 5× · PMID 40673401 · DOI 10.1002/14651858.cd015387.pub2
DPA714 PET Imaging Shows That Inflammation of the Choroid Plexus Is Active in Chronic-Phase Intracerebral Hemorrhage.
Yao S, Gao Z, Fang W, Fu Y, et al · · 2024 · cited 4× · PMID 38054504 · DOI 10.1097/rlu.0000000000004948
Efficacy study of neuronavigation-assisted stereotactic drilling of urokinase drainage versus craniotomy in the treatment of massive intracerebral haemorrhage in elderly patientsa.
Yan Z, Jiang L, Li G, Xia K, et al · · 2024 · cited 2× · PMID 39227662 · DOI 10.1038/s41598-024-71130-x
The Effect of Tranexamic Acid on Neurosurgical Intervention in Spontaneous Intracerebral Hematoma: Data From 121 Surgically Treated Participants From the Tranexamic Acid in IntraCerebral Hemorrhage-2 Randomized Controlled Trial.
Hollingworth M, Woodhouse LJ, Law ZK, Ali A, et al · · 2024 · cited 2× · PMID 38785451 · DOI 10.1227/neu.0000000000002961
Safety and efficacy of urokinase irrigation in deep intracerebral hemorrhage evacuation: a multicenter, open-label, dose-escalation trial
Lin F, He Q, Chen Z, Luo X, et al · · 2026 · DOI 10.21203/rs.3.rs-9094666/v1

Verify or expand the search:

Other First Affiliated Hospital of Fujian Medical University trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04686877 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital of Fujian Medical University
Last refreshed: 12 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04686877.

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