Minimally Invasive Surgery + Drugs for Stroke

(SMAD Trial)

This trial explores a new treatment method for individuals who have experienced a spontaneous brain bleed (intracerebral hemorrhage). It combines minimally invasive surgery to remove the blood clot with deferoxamine, an iron-chelating agent that aims to protect brain cells. The goal is to determine if this combination improves recovery compared to standard care. Suitable candidates for the trial have had a recent spontaneous brain bleed confirmed by a CT scan and were able to perform daily activities independently before the bleed. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in care.

The trial does not specify if you need to stop taking your current medications, but it excludes those on certain blood thinners and those who cannot safely stop long-term anticoagulation. It's best to discuss your specific medications with the trial team.

Research has shown that deferoxamine (DFX), a treatment for brain bleeds, is generally safe for patients. Studies have found that DFX can aid recovery and is well-tolerated by individuals with intracerebral hemorrhage (ICH). In previous research, patients using DFX continued to improve for up to six months after their brain bleed. No strong evidence of serious side effects or safety issues has been found.

Researchers are excited about the combination of minimally invasive surgery (MIS) and deferoxamine for stroke because it offers a two-pronged approach. Unlike standard treatments that mainly focus on clot dissolution, like alteplase, this approach involves physically removing the hematoma and using deferoxamine to reduce iron-induced brain damage. Deferoxamine acts as an iron chelator, potentially limiting further brain injury, while MIS allows for targeted removal of the hematoma, which might lead to faster recovery. This strategy could result in quicker symptom relief and better outcomes for patients with intracerebral hemorrhage compared to current options.

In this trial, participants in one arm will receive intravenous deferoxamine (DFX) as part of a minimally invasive surgery (MIS) approach. Studies have shown that DFX might aid recovery from intracerebral hemorrhage (ICH). Research suggests that DFX can help clear blood clots in the brain and reduce swelling. Specifically, patients who received DFX treatment demonstrated improvement for up to six months after their ICH. This treatment is believed to protect brain cells by reducing damage. While the results are promising, further research is needed to confirm its effectiveness.¹²³⁶⁷