IRB Number:

08-005905

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The procedure is to use image-based surgery (MRI or CT) to provide catheter access to ICH for the intervention, which is a one-time clot aspiration followed by instillation of rt-PA over 72 hours. We propose to test if this intervention facilitates more rapid and complete recovery of function and decreased mortality from this condition compared to conventional medical management without subjecting the patient to craniotomy. The specific objective of this trial is to test the safety of this intervention and assess its ability to remove blood clot from brain tissue.

Who is Eligible to Participate in the Study?

Inclusion Criteria
1. Age 18-80
2. Symptoms less than 12 hours prior to diagnostic CT scan (an unknown time of symptom onset is exclusionary);
3. Intention to initiate surgery within 48 hours after diagnostic CT;
4. First dose can be given within 54 hours after diagnostic CT;
5. Systolic blood pressure <200 mmHg sustained for 6 hours

Exclusion Criteria
1. Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy);
2. Clotting disorders;
3. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenteroligic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
4. Patients with a mechanical valve;
5. Patients with unstable mass or evolving intracranial compartment syndrome;
6. Ruptured aneurysm, AVM, vascular anomaly;
7. Pregnant (positive pregnancy test) or lactating females (likelihood of altered coagulation function associated with the high estrogen/progesterone state);

Minimum Age:

18

Maximum Age:

80

What is Involved With this Study?

1. A MRI (magnetic resonance imaging) scan and a MRA (magnetic resonance angiogram) or a CTA (computed tomography angiogram) will be done. One or both of these procedures is standard for diagnosis of vascular malformation with bleeding in the brain. If either scan does not reveal underlying causes for your stroke, then you will be randomly assigned to either medical treatment or surgical treatment for the bleeding in your brain.

2. A pregnancy test will be done if you are a female of childbearing potential. You must not be pregnant to be in this study.

If you are found to be eligible for this study based on the screening procedures described above, you will be put in one of 2 groups by chance (as in the flip of a coin), either surgical or medical management.

If you are selected to be in the surgical management group, you will receive an injection of the study medication rt-PA. The drug used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug in this research study.

If you are randomly chosen or assigned to the surgical group, you will be taken to a sterile operating room and given an appropriate anesthetic. A neurosurgeon will make a skin incision over the site of the blood clot after giving a local anesthetic. Following this, a hole will be drilled in the skull through the skin opening and an unbendable, hollow drain will be passed into the clot. When the drain is in the right place, suction will be applied to the drain using a syringe to remove as much of the blood clot as possible. A soft rubber drain will be passed through the unbendable drain and the unbendable drain will be removed. The soft rubber drain will be left in the clot in the head and the skin will be closed around the drain. Another CT scan will then be done to see how much clot is left and to make sure that the soft drain is in the middle of the remaining blood clot.

You will then be taken to the intensive care unit. If there is enough blood clot remaining in the brain after the surgery, rt-PA (a drug that breaks up blood clots) along with a saline (salt plus water) fluid will be given into the drain every 8 hours to break up the clot. In between injections, the drain will be attached to a drainage system to allow the clot to come out on its own. Once a day you will be taken to have a CT scan. Injections of rt-PA end after 9 doses have been given or when enough blood has been removed from the clot, whichever comes first. Your vital signs and neurological condition will be monitored daily for the next 6 days and labs will be drawn for the next 6 days to monitor natural chemical levels in the blood related to the bleeding in your brain.

We will remove four one-half teaspoons (a total of 2 teaspoons) of fluid directly from the drain using a syringe and gentle pressure once before and three times after drug treatments 1 and 4. This fluid will be shipped to Wayne State University as part of the study to monitor how your body is reacting to the medication.

The rt-PA injections will stop when either:
1. The size of the bleed has been reduced by 20%,
2. The size of the bleed is less than or equal to one tablespoon of blood,
3. You have reached the maximum number of injections (total of 9),
4. The size of your bleed increases significantly,
5. Your physician decides it is in your best interest to withdraw you from the study.

If you are randomly assigned to the medical group, you will be taken to have a CT scan every day for 4 days. Your vital signs, lab values and neurological condition will be monitored daily for the next 6 days or until discharged from the hospital which ever comes first, to monitor natural chemical levels in the blood related to the bleeding in your brain.

BLOOD DRAWS:
You will have approximately 2 tablespoons of blood drawn each morning during your stay in the hospital for up to 6 days.

QUESTIONNAIRES:
You will be asked some basic demographic and quality-of-life questions after signing the consent form. You will be asked to come back to Mayo Clinic for 2 follow-up visits at 30 and 180 days after your stroke has occurred. You will also be contacted by telephone at approximately 90 days after your stroke to monitor your recovery and record any problems you may be experiencing after your stroke.

How long will the Study run?

180 days

**Attn Mayo Website Development team**
Please list study under Stroke
Thank you!!

Who can I Contact for Additional Information on this Trial?

Alexa Richie, MPH, CCRP
904-953-7839
Richie.alexa@mayo.edu

What is/are the Locations of this Clinical Trial?

• Jacksonville, FL

Last updated: 04/09/2009