Abstract 217: Venous Thromboembolism in Patients With Spontaneous Intraventricular Hemorrhage- Results From the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR) III Trial

Abstract

Introduction: Intraventricular hemorrhage (IVH) occurs in about 40% of patients with intracerebral hemorrhage (ICH) and is associated with higher mortality and worse outcomes than ICH patients without IVH. Venous thromboembolism (VTE) is common in ICH patients but data in IVH patients are limited. Methods: Prospective analysis of adjudicated adverse event reporting of VTE (deep venous thrombosis (DVT) and pulmonary embolism (PE)) during first 180 days in 500 patients enrolled in the CLEAR III trial, a multicenter, double-blind, randomized study comparing external ventricular drain (EVD) + intraventricular recombinant tissue plasminogen activator (rtPA) vs EVD + placebo for treatment of obstructive IVH and intracerebral hemorrhage (ICH) volume <30cc. Outcome measures were 90-day and 180-day mortality, ICU and hospital length of stay (LOS), catheter tract hemorrhage as well as predictors of VTE. Results: VTE was reported in 63 patients (13%); 46 (9%), 11 (2%) and 6 (1%) patients had DVT, PE or both, respectively. VTE occurred between 4 and 209 days from ICH onset. VTE pharmacologic prophylaxis was initiated in 404 (81%) patients, at median of 4 days [range:1-48] from ICH onset. Unfractionated and low molecular weight heparin were used in 71% and 29% patients, respectively. These patients had similar rates of VTE but showed a trend towards higher catheter tract hemorrhages (25 vs 15%, p=0.056) as compared to those who did not receive VTE prophylaxis. Patients who developed VTE had similar 90-d and 180-d mortality and ICU LOS but had prolonged hospital LOS (p=0.012) as compared to those who did not develop VTE. On multivariable analysis, ICH volume was a significant predictor of development of VTE (OR 1.04, 95% CI: 1.01-1.07, p=0.024). Conclusions: The association of IVH with VTE is important but complex, in spite of consideration of early VTE prophylaxis. There was trend towards higher catheter tract hemorrhages in patients receiving VTE prophylaxis. ICH volume was a significant predictor of VTE development. However, mortality and ICU LOS were not affected by VTE development. These results form a basis for future correlation of VTE complications with treatment rendered (thrombolysis versus placebo), with upcoming unblinding of the trial.