Minimally Invasive Surgery + Drugs for Stroke
(SMAD Trial)
What You Need to Know Before You Apply
What is the purpose of this 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.
Do I have to stop taking my current medications for the trial?
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
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.
For those considering joining the trial, this information may provide reassurance about the treatment's safety.12345Why are researchers excited about this trial's treatments?
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.
What evidence suggests that this trial's treatments could be effective for intracerebral hemorrhage?
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
Who Is on the Research Team?
Gursant S. Atwal, MD
Principal Investigator
University of Illinois Hospital & Health Sciences System (UI Health)
Javed Iqbal, MBBS
Principal Investigator
University of Illinois Hospital & Health Sciences System (UI Health)
Are You a Good Fit for This Trial?
This trial is for individuals with spontaneous intracerebral hemorrhage (ICH). Participants will be randomly assigned to one of three groups: surgery plus alteplase and deferoxamine, surgery plus alteplase, or standard medical care. They must meet specific health criteria to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo minimally invasive surgery with intralesional alteplase administration and intravenous deferoxamine for 3 consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 30, 60, and 90 days post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alteplase
- Deferoxamine
Trial Overview
The study tests a new treatment combining minimally invasive surgery (MIS) with drugs alteplase and deferoxamine against MIS with alteplase alone or just standard care. It aims to see if the combination is safe and works better for ICH recovery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients in the investigational arm will receive intravenous deferoxamine (DFX) at 32 mg/kg per day, initiated within 1 hour of randomization and continued for 3 consecutive days. Once the hematoma is deemed stable for intervention, the MIS procedure will involve hematoma evacuation using different techniques tailored for superficial (lobar) and deep hemorrhages within 24 hours of Ictus.
Participants will receive standard medical management for ICH without MIS or deferoxamine, serving as the control group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
Citations
Review article Deferoxamine in intracerebral hemorrhage
We found that DFX was effective in hematoma absorption on day 7 after onset, but the difference was not significant on day 14. DFX could suppress edema ...
The Effect of Deferoxamine on Outcome According to Baseline ...
This was based on the main results of i-DEF, which showed that patients in both the placebo- and deferoxamine-treated groups continued to improve between days ...
Effect of Deferoxamine on Trajectory of Recovery After ...
We found that a large proportion of patients with ICH continue to improve up to 6 months after ICH and that treatment with deferoxamine seemed ...
High-Dose Deferoxamine in Intracerebral Hemorrhage
The main purpose of this study is to determine whether treatment with deferoxamine mesylate is of sufficient promise to improve outcome before pursuing a larger ...
High Dose Deferoxamine in Intracerebral Hemorrhage (Hi-Def ...
We hypothesize that treatment with DFO could minimize neuronal injury and improve outcome in ICH patients. As a prelude to test this hypothesis, we conducted a ...
Study Details | NCT02175225 | Intracerebral Hemorrhage ...
The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate , improves the outcome of patients with brain hemorrhage.
7.
frontiersin.org
frontiersin.org/journals/molecular-neuroscience/articles/10.3389/fnmol.2022.927334/fullIron Neurotoxicity and Protection by Deferoxamine in ...
The results show that deferoxamine was safe and improved the chances of a good clinical outcome. The recent i-DEF trial (Intracerebral ...
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