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CLEAR-III CT Radiology Course Hemorrhage Surveillance & Protocol Decision Making Using CT Objectives • • • • Imaging studies by protocol CT based protocol decisions Taking Stability Measurements Example Subjects – Checking for recurrent hemorrhage – Checking for stability CLEAR III Clinical Protocol CT Based Decision Making Dx CT ICH/IVH Stability Determination EVD Consent & Enrollment Test Article q8hr * Investigator may modify CT timing based on expected endpoint E V D Dosing CT scan Day 1 2 3 4 5 24hrs post last dose = Diagnostic = Stability 6 7 30 72hrs post last dose = Daily PI Review 365 Making Protocol Decisions Based on CT Outdated Clinical Definition of Rebleeding • “Rebleed” – A patient with a known hemorrhage deteriorates and has a CT scan. The scan shows more blood. ** This is the old, "clinical” definition pre Novo 7 trial CLEAR III Trial: Definition of Recurrent Hemorrhage • Stability of ICH, IVH, and catheter tract is determined. – Requires comparing CTdiag and CTstability • On a 3rd Scan, any new or enlarged ICH, IVH or catheter tract bleed is a recurrent hemorrhage. Primary IVH: Cessation of bleeding may be hard to define • Q: “Is IVH without ICH a predisposing condition to ongoing bleeding?” A: Possibly … • Why might this be? – no back pressure to bleeding – 1˚ IVH may continue to enlarge longer than ICH (i.e. 12 vs. 3 hours), ref Brott & Broderick. Recurrent Hemorrhage Day 4 Day 5 Catheter Tract Hemorrhage Example Petechial < 5 mm Day 7 post IVC insertion Confluent without local mass effect <5 mm Day 8 post IVC insertion Confluent with local mass effect >5 mm Day 13 post IVC insertion Catheter Tract Hemorrhage Stabilization Algorithm Is there a new catheter hemorrhage? No Continue Treatment on Regular Schedule Yes What kind of Hemorrhage < 5 ml, or < 5 mm in largest diameter Continue Regular Dosing and CT Schedule > 5 ml, or > 5 mm in largest diameter, with or without local mass effect Hold next dose and obtain a CT scan 12 hours after previous scan. Did the hemorrhage enlarge on the follow-up scan? No Continue Treatment on Regular Schedule Yes Discontinue Injections and get another CT 12 hours later When to hold drug? Answer : Evidence of Recurrent Bleeding • Catheter tract expands by > 5 ml, or > 5 mm linear diameter • ICH expands by 5 ml • IVH diameter expands by 2 mm in multiple locations When to Stop Drug? Answer : Treatment Success Endpoints • Clearance of the IIIrd and IVth ventricles • 80 % clot reduction • Relief of mass effect Clearance of IIIrd & IVth Pre-dosing Post Treatment Relief of Lateral Shift Pre-dosing Post-treatment Methods for Assessing Hemorrhage Change ABC/2 (ICH) Ventricular Clot Measurements (IVH) Modified GRAEB Score (IVH) Measure ICH Volume: ABC/2 Method 1. Choose the slice for the A and B measurements. 2. Measure the longest diameter possible. This is your A measurement. 3. Measure the longest remaining diameter that is perpendicular to your A measurement line. This is your B measurement. 4. Beginning at the base slice, count the number of slices in which the ICH is visible. Multiply this number by the slice thickness in centimeters. This is your C measurement. 5. Multiply A x B x C, and then divide the product by 2. This is your ICH volume in mL (cc). A A’ Measure IVH: Lateral Ventricle Clot Measures • Measure width of clot in most involved ventricle at anterior, middle, and posterior regions on a single CT slice • Keep measurement location consistent across daily CT scans to make comparisons • Increase in 2 or more locations by ≥ 2mm is significant and stability should be reconfirmed before continuing rt-PA. Diagnostic CT Stability CT Timeline Example Subject 1 Ex. Subject 1 Pre-rebleed Ex. Subject 1 04/29/2001 04/30/2001 before after Post-rebleed 04/30/2001 Category: recurrent IVH + new cath. tract Example Subject 2 Timeline Clot Volume vs. Time from Stability Clot Volume [cc]/ Graeb Score 40 35 30 ICH Right Lat Left Lat 3rd 4th Catheter Tract 25 20 15 10 5 0 -5 0 5 10 15 20 Elapsed Time from Baseline Stability [hrs] Ex. Subject 2 Diagnostic CT May 25th at 12:19 Purpose: Identify patient as CLEAR III candidate Ex. Subject 2 Stability CT #1 May 25th at 21:31 (IVC #1 placed 5/25/10 at 14:45) Purpose: Check placement of IVC (SOC) Ex. Subject 2 Diagnostic (5/25/10 12:19) Stability CT #1 (5/25/10 21:31) Anterior: 16.59mm Posterior: 17.93mm ICH ABC/2: 9.49cc Anterior: 18.94mm Posterior: 26.23mm ICH ABC/2: 32.10cc Ex. Subject 2 Stability CT #2 May 26th at 09:44 Purpose: Confirm stability • IVH • ICH • Catheter Tract Ex. Subject 2 Stability CT #1 (5/25/10 21:31) Stability CT #2 (5/26/10 09:44) Anterior: 18.94mm Posterior: 26.23mm ICH ABC/2: 32.10cc Anterior: 17.00mm Posterior: 23.22mm ICH ABC/2: 29.46cc Ex. Subject 2 Stability CT #3 May 26th at 17:32 (IVC #2 placed 5/26/10 at 11:19) Purpose: Confirm Stability after new IVC placement Repeat CT >12hrs Later to Confirm Stability Stability CT #3 (5/26/10 17:32) Stability CT #2 (5/26/10 09:44) Anterior: 17.00mm Posterior: 23.22mm ICH ABC/2: 29.46cc Anterior: 17.42mm Posterior: 24.92mm ICH ABC/2: 23.92cc Catheter Tract: 13.30mm Ex. Subject 2 Stability CT #4 May 27th at 05:30 Purpose: Confirm Catheter Tract Stability Repeat CT >12hrs Later to Confirm Stability Stability CT #3 (5/26/10 17:32) Stability CT #4 (5/27/10 05:30) Anterior: 17.42mm Posterior: 24.92mm ICH ABC/2: 23.92cc Catheter Tract: 13.30mm Anterior: 17.16mm Posterior: 25.53mm ICH ABC/2: 26.92cc Catheter Tract: 12.28mm Lesson • Measure the ventricle diameter accurately in 3 locations to check of IVH stability. • Use ABC/2 to check ICH stability. • Check for catheter tract hemorrhage with insertion and manipulation of all catheters. • If any of these locations show increased bleeding, wait and get another CT before randomizing the patient. * Do not enroll an unstable patient • Don’t give up! What to take home? • Always compare two CT’s. • Look for signs of NEW or EXPANDING: ICH, IVH, Catheter tract blood. • When comparing new to old scan always ask can we stop drug now? – i.e. Is the 3rd and 4th open? Is the lateral shift gone? Has 80% reduction been achieved? (Therefore, I can consider stopping drug now.)