Navigating intracranial haemorrhage

Dr Eitzaz Sadiq, consultant neurologist and lecturer at the University of the Witwatersrand and Head of the Neurology Unit at Helen Joseph Academic hospital

Intracranial haemorrhage (ICH) is a severe complication of stroke, particularly following thrombolysis treatment. Thrombolysis, a critical intervention for ischaemic stroke, dissolves clots and restores blood flow to the brain but increases the risk of haemorrhagic transformation, leading to significant neurological decline.

The definition of symptomatic ICH (sICH) varies across studies, causing discrepancies in case reporting. The National Institute of Neurological Disorders and Stroke defines sICH as any hemorrhagic transformation resulting in neurological deterioration, risking over-diagnosing minor petechial bleeds.

The Safe Implementation of Thrombolysis in Stroke-Monitoring Study criteria offers a stricter definition, considering only haemorrhages associated with significant neurological worsening (more than four points on the NIHSS score) as symptomatic. Depending on the criteria, the incidence of sICH post-thrombolysis ranges from under 2% to 7.4%.

Radiologically, intracranial haemorrhages are classified into haemorrhagic infarctions and parenchymal haematomas. Haemorrhagic infarctions, subdivided into HI1 and HI2, typically involve small petechial bleeds that are often asymptomatic.

In contrast, parenchymal hematomas (PH1 and PH2) are more severe, with PH2 representing large haemorrhages that can cause significant mass effect and worsen outcomes.

Predicting the risk of haemorrhagic transformation after thrombolysis is challenging. Several scoring systems incorporate factors such as age and stroke severity to estimate the risk, but these are not commonly used in clinical practice to determine thrombolysis eligibility.

Patients with the highest risk of haemorrhage often benefit most from thrombolysis. These scores guide post-thrombolysis monitoring and help manage patient and family expectations.

Clinical signs of haemorrhagic transformation include sudden neurological deterioration, decreased consciousness, new headaches, nausea, vomiting, and a sudden rise in BP within 36-hours post-thrombolysis. Most haemorrhages occur within 12-hours of treatment, but monitoring should continue for up to 36-hours as late haemorrhages can occur.

Managing intracerebral haemorrhage following thrombolysis is critical in stroke care. The American Heart Association and American Stroke Association's 2017 guidelines recommend immediately stopping the thrombolysis infusion upon detecting a bleed.

Standard management principles for intracerebral haemorrhage, including maintaining adequate breathing and circulation, controlling BP, and managing intracranial pressure, should be followed.

Reversing the coagulopathy induced by thrombolysis is essential to prevent further hemorrhage expansion. This process involves administering agents that can reverse the effects of alteplase, the thrombolytic drug commonly used. The aim is to stop the bleeding and minimise neurological damage.

Dr Sadiq emphasised the critical role of blood products, specifically cryoprecipitate, fresh frozen plasma (FFP), and prothrombin complex concentrates (PCC), in managing this severe condition. Understanding the coagulation pathway and the timely administration of these agents are crucial for effective treatment.

Cryoprecipitate, containing Factors VIII, XIII, von Willebrand factor, and fibrinogen, is essential in treating ICH. Dr Sadiq stressed that cryoprecipitate can benefit all patients with ICH, but its administration should be guided by fibrinogen level checks.

Without waiting for results, 10 units of cryoprecipitate should be administered, followed by a repeat fibrinogen level test after 30 minutes. This process may need to be repeated until fibrinogen levels reach 150mg/dl.

The key challenge with cryoprecipitate is its availability and the need to thaw it from a frozen state, which can be time-consuming in emergencies. Despite its widespread use, the evidence supporting its effectiveness is limited, relying mostly on expert opinion and small observational studies.

PCC, containing Factors II, VII, IX, and X, along with proteins C and S, is another essential product in managing ICH. However, PCC requires fibrinogen as a substrate, meaning it is less effective if fibrinogen levels are low.

PCC is particularly beneficial for patients on warfarin with depleted factors, but its use increases the risk of thrombotic events. Unlike cryoprecipitate, PCC may need to be used with cryoprecipitate to provide more comprehensive treatment.

However, which also contains multiple clotting factors, can be used as an alternative to PCC. However, FFP poses challenges due to its larger volume and slower administration, which can be problematic in emergency settings. Additionally, the risk of transfusion reactions and the need for thawing make FFP less ideal compared to other options.

Despite its limitations, FFP is still considered for patients on warfarin with ICH, like the use of vitamin K, which also lacks strong evidence for benefit in this context.

Antifibrinolytic agents like aminocaproic acid and tranexamic acid, which inhibit plasmin, were briefly discussed by Dr Sadiq. Although the data supporting their use is limited, ongoing trials show promise. These agents are appealing because they are readily available, work quickly, and do not require thawing, making them practical in emergencies, especially for patients who decline blood products for religious reasons.

The role of platelets in managing ICH was also mentioned, with the suggestion that they might be beneficial in patients with thrombocytopenia, although this is not well-established.

Dr Sadiq emphasised that surgical intervention should only be considered once coagulopathy is reversed. He highlighted the Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial, which explored minimally invasive surgery combined with alteplase catheter irrigation, showing some survival benefits but not meeting primary outcomes.

The ethical dilemma - choosing treatment or not

Dr Johann Smuts, neurologist in private practice, and lawyer

Dr Smuts delivered a compelling presentation on the ethical dilemmas surrounding the treatment of stroke patients, particularly when the treatment options themselves carry significant risks, such as thrombolysis or thrombectomy. Dr Smuts began by addressing the core question: Should we treat a patient knowing the potential for harmful outcomes exists?

He argued that the ethical concern is not whether to treat but rather how to treat. Once a patient enters the care of a physician, there is an ethical obligation to provide treatment.

The dilemma arises when the treatment itself may lead to adverse outcomes, such as bleeding risks associated with thrombolytic therapy. This highlights the importance of balancing the potential benefits of treatment with the risks, a decision that must be made with careful consideration of the patient's condition and the available medical evidence.

He emphasised the growing importance of understanding legal principles in stroke medicine, especially as advancements in treatment raise patient expectations and increase the likelihood of malpractice litigation.

To navigate these legal waters, Dr Smuts structured his discussion around four primary sections:

1. Competency: This refers to a patient's mental capacity to make informed decisions about their treatment. Competency is task-specific, meaning the level of understanding required varies depending on the complexity of the decision. For example, a patient must comprehend the nature of the treatment, the risks involved and be able to communicate their decision effectively. In stroke cases, where cognitive impairments are common, assessing competency becomes particularly challenging.
2. Doctor-patient relationship: The establishment of a doctor-patient relationship is crucial as it forms the legal duty of care. This relationship can be formed through physical, telephonic, or even digital interactions and implies a contractual obligation to provide care. Once treatment is initiated, the relationship persists until formally terminated, and failing to properly conclude this relationship can lead to accusations of patient abandonment, which is a common ground for malpractice suits.
3. Informed consent: Informed consent is not just a formality but a process that ensures the patient makes knowledgeable decisions about their treatment. Dr Smuts highlighted the need for thorough documentation of informed consent, ideally through written forms. The consent process should include explaining the diagnosis, the proposed treatment, its risks, and any reasonable alternatives. In situations where the patient is not competent to give consent, substitute consent from a legal guardian or next of kin may be necessary.
4. Malpractice: Malpractice occurs when there is a duty to treat, a breach of that duty, an injury, and a causal link between the breach and the injury. Dr Smuts explained that the standard of care is a key element in malpractice cases, where the behaviour of the physician, rather than their knowledge, is scrutinised. Deviation from clinical guidelines, especially without proper documentation or patient discussion, can be grounds for malpractice if it leads to patient harm.

Informed consent is particularly critical in stroke treatment due to the high stakes involved. He stressed that informed consent must be more than a simple offer to answer questions. It should be a comprehensive discussion that provides the patient with all necessary information to make an informed choice.

The discussion should cover the nature and seriousness of the condition, the reasons for recommending a specific treatment, the risks involved, and the potential outcomes if the treatment is not administered.

The concept of implied consent was also discussed, particularly in emergency situations where the patient is unable to provide consent. In such cases, treatment is justified based on what a reasonable person would likely choose under similar circumstances. However, even in emergencies, it is crucial to document the decision-making process as thoroughly as possible.

Dr Smuts outlined the four essential elements of malpractice:

1. Duty of care: This is established through the doctor-patient relationship and implies a legal obligation to treat the patient with the expected standard of care.
2. Breach of duty: A breach occurs when the care provided falls below the accepted standard. This could involve doing something wrong (an error) or failing to do something right (an omission).
3. Injury: There must be a significant injury or harm resulting from the breach of duty. Minor injuries or those that do not result in lasting damage are unlikely to support a successful malpractice claim.
4. Causal link: There must be a direct link between the breach of duty and the injury. This link must be more than speculative; it must be shown that the injury was a foreseeable consequence of the breach.

An emerging legal concept in stroke medicine is the doctrine of loss of chance. This doctrine suggests that even if the probability of a better outcome with treatment is <50%, the patient may still have a case if it can be shown that the treatment would have provided a significant chance of improvement that was lost due to the physician's actions or inaction. This concept is gaining traction and could have significant implications for malpractice cases in stroke medicine.

Key messages

1. Managing ICH post-thrombolysis requires immediate cessation of treatment and careful administration of blood products, with cryoprecipitate being vital for stabilising fibrinogen levels.
2. Ethical stroke treatment involves balancing treatment risks with patient competency and informed consent, emphasising the legal obligation to provide care while navigating potential malpractice risks.