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Randomization Emergency Contact V 5.0 Inclusion/Exclusion Baseline Evaluations SBP Management Hematoma Volume NIH Stroke Scale Glasgow Coma Scale Modified Rankin Scale Site Locator Pre-Screener

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Randomization

To Randomize:
https://dcu.musc.edu/atach2

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Emergency Contact

For time-sensitive trial information call:

U.S. toll free: 1-855-870-7205

or: 952-225-0779

Leave name, location, and contact number

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Inclusion/Exclusion Criteria

Inclusion Criteria

* Note: Patients with SBP < 180 should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the eligibility window closes.

Exclusion Criteria

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Evaluations

Baseline Evaluations

Lab Tests (click to expand)

  • Hemoglobin
  • Hematocrit
  • WBC w/ differential
  • Platelets
  • Chemistry panel - include all required (glucose, creatinine, BUN, K+, Na+, Cl-, CO₂ or Bicarb)
    Creatinine
  • Thromboplastin (APTT)
  • INR
  • Pregnancy (women of childbearing age)
  • EKG

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SBP Management

Patient is in:

Elapsed time (hh:mm) from start of nicardipine drip infusion:

00:00 00:15 00:30 00:45 01:00 01:15 01:30 02:30+
Standard Treatment Group Goal: Reduce blood pressure and maintain SBP in range of 140-180 mm Hg.
* - Once the upper target systolic blood pressure (180 mm Hg for the standard treatment group) is reached, the infusion rate of nicardipine is adjusted by 1 to 2.5 mg/hour to maintain SBP within the specified target range of 140-180 mm Hg.
ATACH-II Standard Treatment Study Group
Nicardipine Drip Study Drug Titration Chart
Goal: Reduce blood pressure and maintain SBP in range of 140-180 mm Hg
Elapsed time in hours:minutes from start of nicardipine drip infusion SBP, in mm Hg (use final of multiple readings) Nicardipine, mg/hour Nicardipine, 40 mg/200mL drip rate in mL/hour Comments
00:00 between 180 and 240 5 (initial rate) 25 Monitor BP every 5 minutes.
00:15 If still > 180 * Increase to 7.5 37.5 Monitor BP every 5 minutes.
Once patient reaches SBP goal of <180 mm Hg, titrate to keep SBP within 140-180 mm Hg range *
If SBP falls below 140 mm Hg, decrease drip rate by 1-2.5 mg/hr until SBP returns to 140-180 mm Hg target range (or nicardipine is discontinued).
Do not give a saline fluid bolus unless SBP falls below 110 mm Hg. For patients with elevated ICP, CPP should not fall below 70 mm Hg.
00:30 If still > 180 * Increase to 10 50 Monitor BP every 5 minutes.
Once patient reaches SBP goal of <180 mm Hg, titrate to keep SBP within 140-180 mm Hg range *
If SBP falls below 140 mm Hg, decrease drip rate by 1-2.5 mg/hr until SBP returns to 140-180 mm Hg target range (or nicardipine is discontinued).
Do not give a saline fluid bolus unless SBP falls below 110 mm Hg. For patients with elevated ICP, CPP should not fall below 70 mm Hg.
00:45 If still > 180 * Increase to 12.5 62.5 Monitor BP every 5 minutes.
Once patient reaches SBP goal of <180 mm Hg, titrate to keep SBP within 140-180 mm Hg range *
If SBP falls below 140 mm Hg, decrease drip rate by 1-2.5 mg/hr until SBP returns to 140-180 mm Hg target range (or nicardipine is discontinued).
Do not give a saline fluid bolus unless SBP falls below 110 mm Hg. For patients with elevated ICP, CPP should not fall below 70 mm Hg.
01:00 If still > 180 * Increase to 15 (maximum rate) 75 (max rate) Monitor BP every 5 minutes.
Once patient reaches SBP goal of <180 mm Hg, titrate to keep SBP within 140-180 mm Hg range *
If SBP falls below 140 mm Hg, decrease drip rate by 1-2.5 mg/hr until SBP returns to 140-180 mm Hg target range (or nicardipine is discontinued).
Do not give a saline fluid bolus unless SBP falls below 110 mm Hg. For patients with elevated ICP, CPP should not fall below 70 mm Hg.
01:15 If still > 180 * Monitor at 15 75 (max rate) Monitor BP every 5 minutes.
Once patient reaches SBP goal of <180 mm Hg, titrate to keep SBP within 140-180 mm Hg range *
If SBP falls below 140 mm Hg, decrease drip rate by 1-2.5 mg/hr until SBP returns to 140-180 mm Hg target range (or nicardipine is discontinued).
Do not give a saline fluid bolus unless SBP falls below 110 mm Hg. For patients with elevated ICP, CPP should not fall below 70 mm Hg.
01:30 If still > 180 * Use labetalol 5-20 mg IV bolus q 15 minutes in addition to max rate for 1 hour 75 (max rate) Check lines ; second drug (labetalol) is added if patient not responding sufficiently.
> 02:30 If still > 180 * Consider 3 rd drug option 75 (max rate) Again check lines; consider third drug option if still showing insufficient response to max doses of nicardipine + labetalol.
Once patient has stable BP within target range, monitor BP every 30 minutes for 24 hours.
Intensive Treatment Group.
* - Once the upper target systolic blood pressure (140 mm Hg for the intensive treatment group) is reached, the infusion rate of nicardipine is adjusted by 1 to 2.5 mg/hour to maintain SBP within the specified target range of 110-140 mm Hg. Stop nicardipine drip if SBP falls below 110 mm Hg and give NS fluid bolus.
ATACH-II Standard Treatment Study Group
Nicardipine Drip Study Drug Titration Chart
Goal: Reduce blood pressure and maintain SBP in range of 110-140 mm Hg
Elapsed time in hours:minutes from start of nicardipine drip infusion SBP, in mm Hg (use final of multiple readings) Nicardipine, mg/hour Nicardipine, 40 mg/200mL drip rate in mL/hour Comments
00:00 > 180 & < 240 5 (initial rate) 25 Monitor BP at least every 5 minutes through titration phases. Randomization may take place following start of drip if still within 3 hours of symptom onset, initial SBP falls within 180-240 mm Hg range and did not fall below 180 mm Hg spontaneously, and SBP did not fall below 140 mm Hg following start of drip and prior to randomization.
00:15 If still > 140 * Increase to 7.5 37.5 Monitor BP every 5-15 minutes.
Once patient reaches SBP goal of <140 mm Hg, titrate to keep SBP within 110-140 mm Hg range *
If SBP falls below 110 mm Hg, stop nicardipine and give NS fluid bolus
For patients with elevated ICP, MAP should not fall below 100 without notifying physician and CPP should not fall below 70 mm Hg.
00:30 If still > 140 * Increase to 10 50 Monitor BP every 5-15 minutes.
Once patient reaches SBP goal of <140 mm Hg, titrate to keep SBP within 110-140 mm Hg range *
If SBP falls below 110 mm Hg, stop nicardipine and give NS fluid bolus
For patients with elevated ICP, MAP should not fall below 100 without notifying physician and CPP should not fall below 70 mm Hg.
00:45 If still > 140 * Increase to 12.5 62.5 Monitor BP every 5-15 minutes.
Once patient reaches SBP goal of <140 mm Hg, titrate to keep SBP within 110-140 mm Hg range *
If SBP falls below 110 mm Hg, stop nicardipine and give NS fluid bolus
For patients with elevated ICP, MAP should not fall below 100 without notifying physician and CPP should not fall below 70 mm Hg.
01:00 If still > 140 * Increase to 15 (maximum rate) 75 (max rate) Monitor BP every 5-15 minutes.
Once patient reaches SBP goal of <140 mm Hg, titrate to keep SBP within 110-140 mm Hg range *
If SBP falls below 110 mm Hg, stop nicardipine and give NS fluid bolus
For patients with elevated ICP, MAP should not fall below 100 without notifying physician and CPP should not fall below 70 mm Hg.
01:15 If still > 140 * Monitor at 15 75 (max rate) Monitor BP every 5-15 minutes.
Once patient reaches SBP goal of <140 mm Hg, titrate to keep SBP within 110-140 mm Hg range *
If SBP falls below 110 mm Hg, stop nicardipine and give NS fluid bolus
For patients with elevated ICP, MAP should not fall below 100 without notifying physician and CPP should not fall below 70 mm Hg.
01:30 If still > 140 * Use labetalol 5-20 mg IV bolus q 15 minutes in addition to max rate for 1 hour 75 (max rate) Check lines; second drug (labetalol) added if patient not responding sufficiently.
> 02:30 If still > 140 * Consider 3rd drug option 75 (max rate) Again check lines; consider third drug option if still showing insufficient response to max doses of nicardipine + labetalol.
* - Once the upper target systolic blood pressure (140 mm Hg for the intensive treatment group) is reached, the infusion rate of nicardipine is adjusted by 1 to 2.5 mg/hour to maintain SBP within the specified target range of 110-140 mm Hg. Stop nicardipine drip if SBP falls below 110 mm Hg and give NS fluid bonus.

Please select a treatment group.

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Hematoma Volume

Result of calculation here

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Hematoma Volume Measurement

ABC/2 method to calculate hematoma volume

Results ≥ 60 cm 3 : exclude the patient from ATACH-II


A (length): maximum hematoma diameter in cm:

B (width): maximum diameter perpendicular to A in cm:

CT slice thickness in cm:

Number of slices in which the hematoma is visible:

Calculate
Hematoma Volume

Example


A = 2cm

B = 1cm

C = slice thickness X number of slices = 0.5 x 4 = 2cm

Hematoma volume = 2 X 1 X 2 ÷ 2 = 2cm3




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NIH Stroke Scale

(1a): Level of Consciousness
(1b): LOC Questions (Month, age)
(1c): LOC Commands (Open & close eyes, make fist and let go)
(2): Best Gaze (Both eyes open - patient follows examiner's finger)
(3): Visual (Intoduce visual stimulus/threat to patients visual field quadrants)
(4): Facial Palsy (Show teeth, raise eyebrows, and squeeze eyes shut)
(5a): (Left) Motor Arm (Elevate extremity to 30 deg and score drift/movement)
(5b): (Right) Motor Arm (Elevate extremity to 30 deg and score drift/movement)
(6a): (Left) Motor Leg (Elevate extremity to 30 deg and score drift/movement)
(6b): (Right) Motor Leg (Elevate extremity to 30 deg and score drift/movement)
(7): Limb Ataxia (Finger-nose, heel down shin)
(8): Sensory (Pin prick face, arm trunk and leg - compare sides)
(9): Best Language (Name items, describe a picture and read sentences) View images and text
click image to rotate

You know how.
Down to earth.
I got home from work.
Near the table in the dining room.
They heard him speak on the radio last night.

click image to rotate


(10): Dysathria (Evaluate speech clarity by patient repeating listed words) View Words

MAMA
TIP - TOP
FIFTY - FIFTY
THANKS
HUCKLEBERRY
BASEBALL PLAYER

(11): Extinction and Inattention (Use info from prior testing to identify neglect or double simultaneous tactile)

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Glasgow Coma Scale

Visual

Score Eye Opening
4 Spontaneously
3 To Command
2 To pain
1 None

Verbal

Score Best Verbal
5 Oriented & converses
4 Confused & converses
3 Verbalizes
2 Vocalizes
1 None (mute)

Motor

Score Best Motor
6 Obeys commands
5 Localizes pain
4 Flexion withdrawal
3 Abnormal flexion to pain
2 Abnormal ext to pain
1 None

Calculating Verbal GCS for an intubated patient1

GCS Motor GCS Eye Score
Score 1 2 3 4
1 1 1 1 2
2 1 2 2 2
3 2 2 3 3
4 2 3 3 4
5 3 3 4 4
6 3 4 4 5
1 - J Trauma. 1996;41:514-522

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Modified Rankin Scale

Score Description (click for video)
0 No symptoms. watch video
1 Symptoms but no disability. Able to carry out ALL usual activities. watch video
2 Slight disability. UNABLE to carry out all previous activities but able to look after own affairs with assistance. watch video
3 Moderate disability requiring some help. Able to walk without assistance. watch video
4 Moderate to severe disability. Unable to walk without assistance or attend to bodily needs without assistance. watch video
5 Severe disability, bedridden, unable to walk or attend to won bodily needs without assistance. watch video
6 Death.

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