Assessment of clinical risk factors for haemorrhagic complications in patients undergoing intra-arterial thrombolysis for lower limb ischaemia. Retrospective reviews of consecutive patients subjected to intra-arterial thrombolysis due to lower limb ischemia at the Vascular Center, Malmö University Hospital, during a 5-year period from 2001 to 2005. Two hundred and twenty intra-arterial thrombolytic procedures were carried out in 195 patients (46% women), median age 73 years. Haemorrhagic complications were recorded in 72 procedures (33%), of which 13 were discontinued. Haemorrhage at the introducer and distant sites occurred in 53 and 32 procedures, respectively. Thrombolysis for occluded synthetic grafts was associated with higher risk of haemorrhage (P = 0.043). The platelet count was lower (P = 0.017) and the dose of alteplas higher (P = 0.041) in bleeders than in non-bleeders. Age was not associated with haemorrhage (P = 0.30). Two patients died during thrombolysis, one of them due to intracerebral haemorrhage. The grade of thrombolysis was an independent predictor of both in-hospital amputation (P < 0.001; OR 3.5 [95% CI 2.1-5.8]) and mortality (P = 0.021; OR 3.0 [95% CI 1.2-7.9]). The in-hospital amputation-free survival rate was 85% (188/220). Haemorrhage associated with thrombolysis is common, but does seldom require discontinuation of treatment. Insertion of introducers for local thrombolysis through synthetic grafts, lower platelet count and higher alteplas dose were found to be risk factors for haemorrhage. An algorithm for clinical management of haemorrhage has been proposed.