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Year : 2007  |  Volume : 55  |  Issue : 2  |  Page : 174

Thrombolysis with tissue plasminogen activator: Protocol violation is not an option

Apollo Hospitals, Jubilee Hills, Hyderabad - 500 033, Andhra Pradesh, India

Date of Acceptance09-Feb-2007

Correspondence Address:
Sudhir Kumar
Apollo Hospitals, Jubilee Hills, Hyderabad - 500 033, Andhra Pradesh
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0028-3886.32797

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How to cite this article:
Kumar S. Thrombolysis with tissue plasminogen activator: Protocol violation is not an option. Neurol India 2007;55:174

How to cite this URL:
Kumar S. Thrombolysis with tissue plasminogen activator: Protocol violation is not an option. Neurol India [serial online] 2007 [cited 2023 Dec 2];55:174. Available from:


I read with interest a recent article by Padma et al regarding thrombolysis with tissue plasminogen activator (tPA) in acute ischemic stroke (AIS).[1] However, I would like to make certain observations.

Patients were thrombolyzed without obtaining the coagulation profile in this study. Out of 54, six patients (11.1%) had hemorrhagic complications- five patients developed hemorrhagic infarction (HI) and one developed intracranial hemorrhage (ICH). Though these were asymptomatic and nonfatal, these could result in poor prognosis. In a recent study, the proportion of patients with good outcome after thrombolysis was 41% in those without any hemorrhagic transformation, whereas the proportion dropped to 17-30% in patients with HI and even lower in those with parenchymal hematoma.[2] Another study reported a higher incidence of symptomatic and asymptomatic ICH with protocol violations (prolonged prothrombin time and activated partial thromboplastin time).[3]

The time to reach emergency ranged up to 3.4h in this study. However, it should be noted that intravenous thrombolysis is approved only within 3h of stroke onset. Intravenous thrombolysis beyond 3h increases the rate of symptomatic, asymptomatic and fatal ICH, without improving the recovery rate.[4]

Therefore, I think it is dangerous to perform thrombolysis for AIS with protocol violations (such as without obtaining coagulation profile or after the 3h window period) and every effort should be made to strictly adhere to the NINDS protocol.

 » References Top

1.Padma MV, Singh MB, Bhatia R, Srivastava A, Tripathi M, Shukla G, et al . Hyperacute thrombolysis with IV rtPA of acute ischemic stroke: Efficacy and safety profile of 54 patients at a tertiary referral center in a developing country. Neurol India 2007;55:46-9.  Back to cited text no. 1    
2.Dzialowski I, Pexman JH, Barber PA, Demchuk AM, Buchan AM, Hill MD, et al . Asymptomatic hemorrhage after thrombolysis may not be benign: Prognosis by hemorrhage type in the Canadian alteplase for stroke effectiveness study registry. Stroke 2007;38:75-9.  Back to cited text no. 2    
3.Lopez-Yunez AM, Bruno A, Williams LS, Yilmaz E, Zurru C, Biller J. Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage. Stroke 2001;32:12-6.  Back to cited text no. 3    
4.Clark WM, Wissman S, Albers GW, Jhamandas JH, Madden KP, Hamilton S. Recombinant tissue-type plasminogen activator (Alteplase) for ischemic stroke 3 to 5 hours after symptom onset. The ATLANTIS Study: A randomized controlled trial. Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke. JAMA 1999;282:2019-26.  Back to cited text no. 4    

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Online since 20th March '04
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