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NCT Number: NCT03309579

SAHaRA: A Randomized Controlled Trial

The SAHaRA trial will clarify the role of treating anemia with Red Blood Cell (RBC) transfusion in a unique and vulnerable patient population, and determine whether that impacts on functional outcomes and mortality. It will guide best practice standards and clarify the optimal RBC transfusion strategy in patients with aSAH.

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Key information

Conditions

Subarachnoid Hemorrhage, Aneurysmal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nepean Hospital, Kingswood, New South Wales, Australia

Loading trial locations.

About this study

We hypothesize that in adult patients suffering from aSAH and anemia, a liberal RBC transfusion strategy as compared to a restrictive RBC transfusion strategy decreases the combined rate of death and severe disability at 12 months (using the modified Rankin Scale)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old at time of SAH
  • First ever episode of aneurysmal SAH
  • Diagnosis of aSAH as confirmed by treating physician (eg: neurosurgeon or neuro- interventionalist) and supported by blood in subarachnoid space (e.g. cranial imaging or cerebrospinal fluid positive for xanthochromia, surgical visualization) that is the result of a ruptured aneurysm (e.g. direct visualization, cranial imaging or catheter angiogram)
  • Hb ≤100g/L within 10 days following aSAH (defined by first day of hospital presentation)

Exclusion criteria

  • Physician and or family decision to withdraw/withhold active medical care at time of enrolment
  • Active bleeding with hemodynamic instability at time of enrolment
  • Patients with contraindication or known objection to blood transfusions
  • SAH due to mycotic aneurysm, infundibulum and vascular malformations.

Treatment and study plan

Liberal RBC Transfusion Strategy

Other

RBC transfusion is triggered by a Hemoglobin value of ≤100g/L

Restrictive RBC Transfusion Strategy

Other

Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L

Primary outcomes

  1. Modified Rankin Scale (mRS)

    Time frame: 12 months post

    The Modified Rankin Scale (mRS) is a functional outcome measure in stroke. The interview consists of five sections: Constant Care, Assistance to Attend to Bodily Needs/For Walking, Assistance to Look After Own Affairs, Usual Duties and Activities and Symptoms as a Result of Stroke.

    The scale is scored from 0 reporting no symptoms at all, to 5 reporting severe disability. Death is indicated by a score of 6.

Secondary outcomes

  1. Functional Independence Measure (FIM)

    Time frame: 12 months post

    The Functional Independence Measure (FIM) assesses the level of a patient's disability considering the amount of support needed to care for them.Items are scored on the basis of how much assistance is required for the individual to carry out activities of daily living.

    The FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition.

    Each item is scored on a 7 point ordinal scale, ranging from 1 to 7. The 2 subscales are then added to give a total FIM score between 18 and 126. The higher the score, the more independent the patient is in performing activities of daily living.

  2. EuroQOL Quality of Life Scale (EQ5D)

    Time frame: 12 months post

    The EQ-5D measures generic health status. There are 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety/Depression which are answered by 5 Problem Levels: None, Slight, Moderate, Severe and Unable. The result is a 5 digit number, 11111 indicating no problem in any dimension to 55555 indicating unable to complete in all dimensions.

    Quality of life is also assessed on a visual analog scale reported from 0 being the worst imaginable health status to 100 as the best imaginable health status.

  3. Red Blood Cell Transfusions

    Time frame: up to 21 days

    The total number of red blood cell transfusions received.

  4. Daily Hemoglobin

    Time frame: up to 21 days

    The lowest daily hemoglobin values.

  5. Transfusion-related Complications

    Time frame: up to 28 days

    Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock.

  6. Delayed Cerebral Ischemia and Vasospasm

    Time frame: up to 28 days

    The incidence and severity of delayed cerebral ischemia and vasospasm.

  7. Cerebral Infarction

    Time frame: up to 28 days

    The incidence of cerebral infarctions.

  8. Mechanical Ventilation

    Time frame: up to 21 days

    If required, the duration of mechanical ventilation.

  9. Length of Stay

    Time frame: 12 months post

    The length of ICU or hospital stay.

  10. Mortality

    Time frame: 12 months post

    The number of deaths.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2017
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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