27-10-2023On 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’.
12-09-2023Local 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.
24-07-2023Isala 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.
14-06-2023MUMC+ 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.
01-06-2023During 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.
On May 3rd, Isala included their first run-in patient! Read more in the DIST newsletter of May 2023 (#6) here.
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.
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.
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’.
Read our fourth DIST newsletter of March 2023 (#4) here.
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.
Amsterdam UMC is now officially live and ready for inclusion.
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.
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.
The Dutch ICH Surgery Trial is officially LIVE! The Radboudumc and Erasmus MC are initiated and ready for inclusion.
The Medical Ethical Committee has given approval to start the trial!
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.
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.
The DIST has been submitted to the medical ethics committee for approval.