Risk Stratification and Minimally Invasive Surgery in Acute ICH Patients

NCT03862729 | Unknown DMC

• 1 other identifier: GN-2018R002
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

The study consists of 2 parts: the first part is to conduct a multicenter retrospective analysis of more than 1000 acute ICH patients treated by conservative observation from 33 centers in China to create a predictive model of intracerebral hemorrhage growth based on clinical, blood, genetic, imaging, and pharmacological factors; the second part is to validate the efficacy of the minimally invasive surgery, including stereotactic thrombolysis and endoscopic surgery, in 300 eligible patients with high risk of hemorrhage growth according to the first part results in a prospective multicenter cohort study.

Conditions

Spontaneous Intracerebral Hemorrhage

Keywords

Risk stratification; minimally invasive surgery; early-stage ICH patient; prospective cohort study

Outcome Measures

Primary Outcomes (1)

• Severe disability or Death

  The prespecified primary endpoints are severe disability or death defined as Barthel Index ≤60 at 1 year after intracranial hemorrhage.

  1 Year

Secondary Outcomes (2)

• All-cause mortality

  1 year

• Complications

  1 year

Study Arms (2)

Early minimally invasive surgery group

For patients in minimally invasive surgery group, intracranial hematoma will be removed by intraoperative stereotactic computer tomography-guided endoscopic surgery, or surgical aspiration followed by alteplase clot irrigation (1·0 mg every 8 h for up to nine doses). CTA will be performed before operation in all the patients for intraoperative navigation, and the minimally invasive surgery will be performed within 24 hours after intracerebral hemorrhage onset.

Procedure: Minimally invasive surgery

conventional treatment group

Eligible patients not accepting early minimally invasive surgery are classified as the conventional treatment group. Conventional treatment includes medical treatment and conventional craniotomy. According to the intention-to-treat principle, patients treated by minimally invasive surgery beyond the 24 hours interval after ICH onset are also classified as conventional treatment group.

Procedure: conventional treatment

Interventions

Minimally invasive surgery PROCEDURE

Intracranial hematoma will be removed by intraoperative stereotactic computer tomography-guided endoscopic surgery, or surgical aspiration followed by alteplase clot irrigation (1·0 mg every 8 h for up to nine doses). CTA will be performed before operation in all the patients for intraoperative navigation, and the minimally invasive surgery will be performed within 24 hours after intracerebral hemorrhage onset.

Early minimally invasive surgery group

conventional treatment PROCEDURE

Conventional treatment includes medical treatment and conventional craniotomy.

conventional treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In the retrospective part, at least 1000 conservatively treated acute ICH patients during the last 5 years from 31 Grade Ⅲ A level hospitals and 2 Grade Ⅱ A level hospitals distributed all over China will be enrolled. Patients should have undergone baseline CT scan within 24 hours after hemorrhage onset and repeated fewer than 48 hours. In the prospective part, at least 300 cute ICH patients with high risk of hemorrhage growth, according to the results of first part, from the same hospitals will be enrolled. All patients in this study should meet the inclusion and exclusion criteria. Informed written consent should be obtained from eligible adult patients or from the guardians of eligible pediatric patients. All patients in the prospective part of this study can withdraw at any time.

You may qualify if:

• Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patient with a small amount of intraventricular hemorrhage is eligible);
• Patients should have undergone baseline CT scan within 48 hours after hemorrhage onset and repeated fewer than 48 hours after the baseline CT;
• Patients without herniation.
• Patients were treated by observation before hemorrhage growth (if happened).

You may not qualify if:

• Spontaneous intracerebral hemorrhage secondary to an underlying structural cause identified by brain imaging, (ie, vascular malformation, aneurysm, tumor);
• The time from symptom onset to baseline imaging was not known in hours, clinical information or lab results was not enough to determine the growth of the hematoma or to perform statistical analysis;
• Patients had accepted acute treatment that might have reduced intracerebral hemorrhage volume (ie, surgical evacuation, external ventricular drainage, lumbar puncture).
• Prospective part
• Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patient with a small amount of intraventricular hemorrhage is eligible);
• Patients without herniation meet the clinical uncertainty principle as follows: the responsible neurosurgeon is uncertain about the benefits of surgery.
• Patients should have undergone baseline CT scan within 24 hours after hemorrhage onset; the volume of the hematoma is more than 20 ml and less than 100ml on the first CT scan.
• Patients with a Glasgow coma score of 5 or more.
• Informed consent, and willing to accept long-term follow-up.
• Spontaneous intracerebral hemorrhage secondary to an underlying structural cause identified by brain imaging, (ie, vascular malformation, aneurysm, tumor);
• patients had a cerebellar hemorrhage or extension of a supratentorial hemorrhage into the brainstem;
• patients had severe pre-existing physical or mental disability or severe comorbidity that might interfere with the assessment of outcome.
• Severe coagulopathy, INR cannot be reversed to less than or equal to 1.5
• Patients during pregnancy or lactation.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead
• National Health and Family Planning Commission, P.R.China: collaborator

Study Sites (1)

The first affiliated hospital of fujian medical university

Fuzhou, Fujian, 350005, China

RECRUITING

Related Publications (4)

• Yao S, Gao Z, Fang W, Fu Y, Xue Q, Lai T, Shangguan H, Sun W, Lin Y, Lin F, Kang D. DPA714 PET Imaging Shows That Inflammation of the Choroid Plexus Is Active in Chronic-Phase Intracerebral Hemorrhage. Clin Nucl Med. 2024 Jan 1;49(1):56-65. doi: 10.1097/RLU.0000000000004948. Epub 2023 Nov 29.

  PMID: 38054504 DERIVED

• Li JB, Lin XR, Huang SN, He Q, Zheng Y, Li QX, Lin FX, Zhuo LY, Lin YX, Kang DZ, Ma K, Wang DL. High Plasma Fibrinogen Level Elevates the Risk of Cardiac Complications Following Spontaneous Intracerebral Hemorrhage. World Neurosurg. 2023 Dec;180:e774-e785. doi: 10.1016/j.wneu.2023.10.044. Epub 2023 Oct 13.

  PMID: 37839573 DERIVED

• Lin F, He Q, Zhuo L, Zhao M, Ye G, Gao Z, Huang W, Cai L, Wang F, Shangguan H, Fang W, Lin Y, Wang D, Kang D. A nomogram predictive model for long-term survival in spontaneous intracerebral hemorrhage patients without cerebral herniation at admission. Sci Rep. 2023 Feb 22;13(1):3126. doi: 10.1038/s41598-022-26176-0.

  PMID: 36813798 DERIVED

• Ye G, Huang S, Chen R, Zheng Y, Huang W, Gao Z, Cai L, Zhao M, Ma K, He Q, Lin F, Lin Y, Wang D, Fang W, Kang D, Wu X. Early Predictors of the Increase in Perihematomal Edema Volume After Intracerebral Hemorrhage: A Retrospective Analysis From the Risa-MIS-ICH Study. Front Neurol. 2021 Jul 27;12:700166. doi: 10.3389/fneur.2021.700166. eCollection 2021.

  PMID: 34385972 DERIVED

MeSH Terms

Interventions

Minimally Invasive Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 5, 2019
• Study Start: July 1, 2019
• Primary Completion: March 30, 2022
• Study Completion: March 31, 2022
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)