News
14-03-2025
On February 17th, the fourth amendment of the study protocol was accepted by the MEC. The most important changes are specification statistical analysis regarding imputation for missing data and handling of non-consenting participants, adjustment of timeline, specification of deferred consent study, expansion of study committees. Next to that, some textual changes have been made to the PIFs (A1, A2, B1, B2, C1 and C2). The most current versions of all updated documents, can be found on the website under ‘Trial protocol and documents’.27-01-2025
Last month, our team published an article in The Lancet Regional Health Europe on the incidence and outcome of intracerebral hemorrhage.In this systematic review and meta-analysis of 70 prospective population-based studies published between 2008 and 2023, we found a global incidence of 29.2 per 100,000 person-years. The incidence was lower in women than in men, increased with age, and was higher in lower-income countries compared to higher-income countries. In addition, we found a 1-month mortality of 35.5% and only 31.2% of all patients had a good functional outcome after 3 to 12 months. We found no relevant trends over time.
These results demonstrate the persistent major impact of intracerebral hemorrhage. In addition, these results emphasize the importance of conducting studies on new acute treatments for intracerebral hematomas, including DIST.
Click here to read the full article.
27-01-2025
The October edition of the Journal of Neurology & Neurosurgery (TNN) published an article in which we as a DIST team look at the landmark trials available to date in which neurosurgical treatment in patients with intracerebral hemorrhages has been investigated.In our opinion, these studies do not yet provide sufficient evidence to change clinical practice, but the results of recent research give hope that neurosurgical treatment of patients with supratentorial intracerebral hemorrhage can improve functional outcome. The questions about the optimal surgical technique, the optimal time of surgery, and which patients benefit from surgery and which do not, currently remain unanswered. It is therefore very important that the DIST and the other ongoing studies are completed to provide answers to these outstanding questions.
The entire article can be read via this link.
10-01-2025
Looking back at 2024, and the published systematic review and meta-analyses on the incidence, case fatality and functional outcome of intracerebral haemorrhage, according to age, sex and country income level. Find out more in the DIST newsletter of January 2025 (#21) (DIST nieuwsbrief #21 (januari 2025)).08-02-2024
MUMC+ has completed the run-in phase with success and got off with a great start as 6th randomizing center in the DIST with including 2 patients!UMCG included 2 patients in the run-in phase and MST included their first run-in.
23 January 2024 amendment 3 has been approved by the MEC. This amendment comprises the addition of Maasstad hospital as referring center and adjustments in the structure of the deferred consent questionnaire. Read more in the DIST newsletter of February (#13) here.
27-10-2023
On October 13th, the second amendment of the study protocol was accepted by the MEC. The most important change is the addition of a questionnaire on deferred consent at 90 days. The most current versions of all updated documents, can be found on the website under ‘’Trial protocol and documents’.12-09-2023
Local approval has been obtained in the UMCU and as of 12-09-2023 the UMCU has officially started as the 5th center to include patients in the DIST! In addition, the first annual sounding board meeting in the context of the Promising Care Subsidy Scheme took place on September 12, during which the progress of the study was discussed and tips and ideas were exchanged. Find out more in the DIST newsletter of September 2023 (#9) here.24-07-2023
Isala has successfully completed the run-in phase of the DIST. As of July 24, Isala officially started as the 4th center to include patients in the DIST!Additionally, MUMC+ has included their second run-in case and as of June 27th, the ETZ also started with the run-in phase. Read more in the DIST newsletter of July 2023 (#8) here.
14-06-2023
MUMC+ has included their first run-in patient. Moreover, UMCG has started with the run-in phase. Read more in the DIST newsletter of June 2023 (#7) here.01-06-2023
During the AANS and ESOC, the first results of the ENRICH (NCT02880878) trial were presented. ENRICH is an adaptive RCT, which investigated whether early hematoma evacuation (<24 hours) by minimally invasive surgery (the MIPS technique) improves the functional outcome of patients with a spontaneous supratentorial hemorrhage. Inclusion criteria include a hematoma volume of 30-80 mL and a GCS score of 5-14. The 300 patients included were randomized 1:1 between MIPS and the control group. Bayesian analysis found a statistically significant improvement in functional outcome (utility weighted mRS at 6 months) in the MIPS group. This improvement seems to be mainly due to the strong positive effect of MIPS for patients with a lobar hemorrhage. No improvement in functional outcome was found in patients with deep cerebral hemorrhage. Despite these first positive reports, we have decided to continue the DIST in its current form. After the publication becomes available, we will formally discuss the results and implications of ENRICH again and then formally conclude; our expectation is that we will continue DIST as planned.13-05-2023
On May 3rd, Isala included their first run-in patient! Read more in the DIST newsletter of May 2023 (#6) here.
08-05-2023
We are very pleased to announce the latest publication of the DIST pilot study group in Acta Neurochirugica (Wien):
Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study | SpringerLink
In preparation of the Dutch ICH Surgery Trial, that already randomized its first patients, we engaged in ensuring the safety and technical efficacy of minimally invasive endoscopy guided surgery for intracerebral hemorrhage within 8 hours after symptom onset.
We need to progress our work within the DIST to determine whether this intervention also improves functional outcome of patients with this detrimental disease with its current high mortality and morbidity.
13-04-2023
The team in Amsterdam has included their first patient in the DIST! In addition, HMC, Isala, MST and MUMC+ have started the run-in phase.
24-03-2023
On March 17th, the first amendment of the study protocol was accepted by the MEC. The most important changes are the addition of the EQ-5D-5L assessment on day 6 and the separate information letters 'patient in 2e instantie’ and ‘na overlijden’. The most current versions of all updated documents, can be found on the website under ‘’Trial protocol and documents’.
09-03-2023
Read our fourth DIST newsletter of March 2023 (#4) here.
26-01-2023
The DIST has had a positive start to 2023, with the DIST going live in Amsterdam and the inclusion of new participants in the Erasmus MC. Furthermore, MST, Isala and MUMC+ are almost ready to start the run-in phase of the DIST. Find out more in the DIST newsletter of January 2023 (#3) here.
13-01-2023
Amsterdam UMC is now officially live and ready for inclusion.
07-12-2022
On November 29th, the first patient was included in the Radboudumc! In addition, Erasmus MC has included two more patients in the past month, bringing the counter to 4 inclusions! Read our second DIST newsletter of December 2022 (#2) here.
08-11-2022
On November 3rd, the first patient was included in the DIST in the Erasmus MC! With this first inclusion, the DIST has officially started.
Read our first DIST newsletter of November 2022 (#1) here.
10-10-2022
The Dutch ICH Surgery Trial is officially LIVE! The Radboudumc and Erasmus MC are initiated and ready for inclusion.
05-08-2022
The Medical Ethical Committee has given approval to start the trial!
07-04-2022
On April 5, 6 and 7, the neurosurgeons were trained in the minimmaly invasive endoscopy-assisted procedure and the use of the Artemis neuro-evacuation device.
02-03-2022
The DIST has been awarded the Veelbelovende Zorg (Promising Care) grant from the Zorginstituut Nederland and ZonMw. The awarded grant of 5 million euros enables us to extend the follow-up of all participants from 6 to 12 months, perform a cost-effectiveness and budget impact analysis, and to reimburse the costs of the procedure during the trial. See also: https://www.radboudumc.nl/nieuws/2022/groot-onderzoek-naar-effect-nieuw-soort-operatie-na-hersenbloeding.
14-02-2022
The DIST has been submitted to the medical ethics committee for approval.