CompletedPhase 2

Clinical Trial on Treatment of Intraventricular Hemorrhage

United States52 participantsStarted 2004-02

Plain-language summary

The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age 18-75
✓. IVC placed as standard of care using less than or equal to 2 complete passes.
✓. Spontaneous ICH less than or equal to 30 cc.
✓. Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours).
✓. Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method).
✓. ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT).
✓. SBP \< 200 mmHg sustained for 6 hours.
✓. Historical Rankin of 0 or 1.

Exclusion criteria

✕. Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI).
✕. Clotting disorders.
✕. Patients with platelet count \< 100,000, INR \> 1.7, PT \> 15s, or an elevated APTT.
✕. Pregnancy (positive pregnancy test).
✕. Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded).
✕. SAH (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study).
✕. ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement).
✕. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.

What they're measuring

30-day Mortality

Timeframe: 30 days

Incidence of Bacterial Ventriculitis, Meningitis

Timeframe: 30 days

Rate of Symptomatic Bleeding Events

Timeframe: 30-days

Trial details

NCT IDNCT00650858

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-08

Results submitted2009-03-12

View on ClinicalTrials.gov More Intraventricular Hemorrhage trials