Plasmic and French scores can be used to predict ADAMTS13 deficiency1 
 Plasmic and French scores are based on laboratory parameters such as platelet count and creatinine level.2

Plasmic score

French score

ACQUIRED-THROMBOTIC-THROMBOCYTOPENIA-PURPURA-ATTP

RARE-BLOOD-DISORDERS

Diagnosing aTTP

See aTTP† — Diagnosis determined through clinical assessment
Start Cablivi* — Consider early administration of Cablivi in combination with PEX and immunosuppressive therapy
Support with AdamTS13 — AdamTS13 test results inform treatment decisions

<h2>ISTH TTP Guidelines are the first evidence-based, international guidelines on the diagnosis, treatment, and management of aTTP1,2</h2>

Treatment recommendations have evolved to include PEX, immunosuppressive therapy,&nbsp;and CABLIVI

Initiation of CABLIVI is recommended for&nbsp;acute aTTP events(initial and relapsing)

Starting CABLIVI early&nbsp;is believed to have the greatest benefit in the early phase of acute aTTP events (initial or relapsing)

<h3>Who should not start Cablivi?</h3>
<ul>
 <li>Cablivi is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients</li>
 <li>Withhold Cablivi treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions</li>
</ul>
* A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. Assumes timely access to ADAMTS13 testing and clinical diagnosis based on high likelihood of aTTP. If ADAMTS13 testing is not available, do not add Cablivi. †The ISTH TTP Guidelines refer to aTTP as iTTP.
<h3>Indications:</h3>
Cablivi (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP),in combination with plasma exchange and immunosuppressive therapy.
<h3>Important safety information contraindications:</h3>
Cablivi is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients. Hypersensitivity reactions have included urticaria.

Abbreviations

<h3>See aTTP—Diagnosis determined through clinical assessment1</h3>
aTTP is a life-threatening blood disorder with considerable morbidity and mortality in the acute phase

See aTTP—Diagnosis determined through clinical assessment1
aTTP is a life-threatening blood disorder with considerable morbidity and mortality in the acute phase

<h2>Diagnose aTTP through clinical assessment or risk assessment tools prior to ADAMTS13 testing</h2>

<h3>Clinical assessment†</h3>
<ul>
 <li>Thrombocytopenia (&lt;150 × 109/L)</li>
 <li>Evidence of microangiopathic hemolytic anemia</li>
 <li>– Hb and hematocrit below reference range</li>
 <li>– Low haptoglobin</li>
 <li>– Presence of schistocytes in peripheral blood smear 
 <ul>
 <li>Relatively preserved renal function</li>
 </ul></li>
</ul>

<h3>Risk assessment tools†</h3>
Available risk assessment tools include:
<ul>
 <li>PLASMIC score</li>
 <li>French score</li>
</ul>
The higher the risk assessment score the more likely patients have severe ADAMTS13 deficiency and aTTP

<h3>Identifying aTTP is crucial for initiation of an appropriate therapeutic strategy</h3>
*A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. 
 Assumes timely access to AdamTS13 testing and clinical diagnosis based on high likelihood of aTTP. If AdamTS13 testing is not available, do not add CABLIVI. †List includes laboratory tests and results only; exclusive of physical symptoms, such as petechiae. ‡ISTH did not appraise the evidence of these 2 tools.
<h3>Important safety information (cont’d) Warnings and Precautions:</h3>
<ul>
 <li>Cablivi increases the risk of bleeding. Cases of major bleeding, including life-threatening and fatal bleeding have been reported in patients receiving Cablivi, mainly in those using concomitant anti-platelet agents or anticoagulants. The risk of bleeding is increased in patients with underlying coagulopathies and concomitant use of Cablivi with drugs affecting hemostasis.</li>
 <li>In clinical studies, severe bleeding adverse reactions of epistaxis, gingival bleeding, upper gastrointestinal hemorrhage, and metrorrhagia were each reported in 1% of subjects. Overall, bleeding events occurred in approximately 58% of patients on Cablivi versus 43% of patients on placebo.</li>
 <li>If clinically significant bleeding occurs, interrupt use of Cablivi . Von Willebrand factor concentrate may be administered to rapidly correct hemostasis. If Cablivi is restarted, monitor closely for signs of bleeding.</li>
 <li>Withhold Cablivi for 7 days prior to elective surgery, dental procedures or other invasive interventions. If emergency surgery is needed, the use of von Willebrand factor concentrate may be considered to correct hemostasis. After the risk of surgical bleeding has resolved, and Cablivi is resumed, monitor closely for signs of bleeding.</li>
</ul>

Start CABLIVI*—Consider early administration of CABLIVI in combination with PEX and immunosuppressive therapy1 
 Recommended diagnostic and management strategy for acute events with access to ADAMTS13 results within 7 days

<h2>Treatment of relapses for a patient previously diagnosed with aTTP could be started safely based on clinical grounds without the need for a confirmatory AdamTS13 test</h2>
<h3>Who should not start Cablivi?</h3>
<ul>
 <li>Cablivi is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients</li>
 <li>Withhold Cablivi treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions</li>
</ul>
* A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. Assumes timely access to AdamTS13 testing and clinical diagnosis based on high likelihood of aTTP. If AdamTS13 testing is not available, do not add Cablivi.
<h3>Important safety information (cont’d) adverse reactions:</h3>
The most common adverse reactions (&gt;15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
<h3>Concomitant use of anticoagulants:</h3>
Concomitant use of Cablivi with any anticoagulant may increase the risk of bleeding. Assess and monitor closely for bleeding with concomitant use.

Support with AdamTS13—AdamTS13 test results inform treatment decisions1 
 Timely access to AdamTS13 results is key to providing optimal care for patients with aTT

<table align="center" border="0" cellpadding="1" cellspacing="1" style="height: 380px; width: 1500px;">
 <tbody>
 <tr>
 <td colspan="2" style="background-color: rgb(244, 242, 247);">Select US labs testing AdamTS13 activity, inhibitors, and antibodies</td>
 </tr>
 <tr>
 <td>ARUP Labs</td>
 <td>800-522-2787</td>
 </tr>
 <tr>
 <td>LabCorp</td>
 <td>800-334-5161</td>
 </tr>
 <tr>
 <td>Machaon Diagnostics</td>
 <td>800-566-3462</td>
 </tr>
 <tr>
 <td>Mayo Clinic Laboratories</td>
 <td>800-533-1710</td>
 </tr>
 <tr>
 <td>Quest Diagnostics</td>
 <td>866-697-8378</td>
 </tr>
 <tr>
 <td>Versiti</td>
 <td>800-245-3117 x6250</td>
 </tr>
 </tbody>
</table>
These listings do not constitute an endorsement by Sanofi Genzyme and are not included in the ISTH Guidelines. The following is a selection of national laboratories offering AdamTS13 tests activity, inhibitor, and antibody testing. This is not an exhaustive list of labs that offer one or more of these tests or an endorsement of any lab. Other testing options may be available, including at local or regional laboratories. Content is current as of July 2020, and tests may not be available in all states. Please call laboratory to confirm test availability, sample shipping information, and all other logistics.

<h3>Prescribe Cablivi—the first and only FDA-approved, guideline-recommended therapy for aTTP in combination with PEX and immunosuppressive therapy</h3>
* A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. Assumes timely access to AdamTS13 testing and clinical diagnosis based on high likelihood of aTTP. If AdamTS13 testing is not available, do not add Cablivi.
<h4>Important safety information (cont’d) pregnancy:</h4>
<ul>
 <li>Pregnancy: There are no data on the use of caplacizumab in pregnant women. Studies in guinea pigs showed no effect of caplacizumab on the dams or foetuses. As a precautionary measure, it is preferable to avoid the use of Cablivi during pregnancy.</li>
 <li>Breastfeeding: There are no data on the use of caplacizumab in breastfeeding women. It is unknown whether caplacizumab is excreted in human milk. A risk to the child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to abstain/discontinue from therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.</li>
</ul>

Reference

ISTH Guidelines

<h2>Identifying thrombotic thrombocytopenic purpura (TTP) among thrombotic microangiopathies (TMAs)</h2>
<h3>TMAs require urgent management, but variable presentation can make them difficult to distinguish1,2</h3>
TMA is a pathologic term used to describe occlusive microvascular or macrovascular disease, often with intraluminal thrombus formation.3&nbsp;Presentation of TMAs varies widely, including but not limited to stroke, neurologic complications, severe renal failure, flu-like symptoms, and simple fatigue.4,5 
 This leads to the involvement of several physician specialists at the outset of patient care in clinic and hospital settings. Both—the variability of TMAs and the involvement of many specialties—pose a challenge to prompt recognition and diagnosis of TTP.4,5
<h3>Your role is crucial to the diagnosis and speed of appropriate treatment for TMAs6</h3>
In most cases, patients present at the emergency department for a nonspecific somatic complaint, and thrombocytopenia is subsequently discovered. More rarely, the results of a CBC can reveal thrombocytopenia during an appointment in a non-hospital setting.6
It is critical to suspect TMA when you see7,8:

Thrombocytopenia 
 (often platelets &lt;30 × 109/L)

Microangiopathic hemolytic anemia (MAHA) 
 characterized by the presence of schistocytes in blood smear

Organ failure 
 of varying severity

Thrombocytopenia associated with MAHA should suggest a TMA syndrome, even in the absence of organ failure.9
Important TMA lab markers6,10,11
<h3>Biological report sheet</h3>

<table align="center" border="0" cellpadding="1" cellspacing="1">
 <tbody>
 <tr>
 <td colspan="1" rowspan="2">Blood count</td>
 <td>Thrombocytopenia</td>
 <td>&nbsp;</td>
 </tr>
 <tr>
 <td>
 Hemolytic anemia</td>
 <td>&nbsp;</td>
 </tr>
 <tr>
 <td>
 Reticulocyte count</td>
 <td>
 High (&gt;120 g/L)*</td>
 <td>&nbsp;</td>
 </tr>
 <tr>
 <td>Hemoglobin</td>
 <td>Low</td>
 <td>&nbsp;</td>
 </tr>
 <tr>
 <td>
 Schistocytes on blood smear</td>
 <td>
 Present†</td>
 <td>A hallmark of TTP, but absence 
 does not rule out a diagnosis</td>
 </tr>
 <tr>
 <td>
 Coombs test</td>
 <td>
 Negative‡</td>
 <td>&nbsp;</td>
 </tr>
 <tr>
 <td colspan="1" rowspan="3">
 Hemolysis evaluation</td>
 <td>Hyperbilirubinemia</td>
 <td>&nbsp;</td>
 </tr>
 <tr>
 <td>
 Haptoglobin low, even undetectable</td>
 <td>&nbsp;</td>
 </tr>
 <tr>
 <td>&nbsp;High LDH rate§</td>
 <td>While not diagnostic, elevated LDH 
 may predict organ damage</td>
 </tr>
 <tr>
 <td colspan="1" rowspan="3">
 Hemostasis assessment</td>
 <td>
 Most often normal</td>
 <td>&nbsp;</td>
 </tr>
 <tr>
 <td>D-dimer rate may be moderately elevated</td>
 <td>&nbsp;</td>
 </tr>
 </tbody>
</table>

<h3>Understanding the types of TMAs can change how you treat the patient1,12</h3>
TMAs are classified into 2 types: primary and secondary. Primary TMAs have no clear underlying cause, while secondary TMAs may be caused by a number of clinical conditions. Recognizing the underlying cause, or lack thereof, can determine treatment course.1,12
Types of TMAs1,12

Primary TMAs
<ul>
 <li>TTP (acquired/immune-mediated and hereditary)</li>
 <li>HUS (atypical/complement-mediated and Shiga toxin–producing E coli)</li>
</ul>

Secondary TMAs
<ul>
 <li>Systemic lupus erythematosus</li>
 <li>Pregnancy-associated (eg, hemolysis, elevated liver enzymes, low platelet count [HELLP] syndrome)</li>
 <li>Hematopoietic progenitor cell transplantation</li>
 <li>Drug-induced</li>
</ul>

<h3>The 2 primary TMAs—TTP and HUS—are often confused, but differentiating them is critical to determining appropriate treatment1,2</h3>
Historically, TTP and hemolytic uremic syndrome (HUS) were classified based on clinical findings: TTP for predominant neurologic involvement and HUS for the kidney-dominant diseases.1,13&nbsp;With recent understanding of the molecular basis of TMAs, definitions have changed.1,7,8,11,13

TTP is now defined as 
 ADAMTS13 deficiency

vs

HUS may be caused by Shiga toxin-producing E coli (STEC-HUS) OR genetic mutations in complement regulatory proteins (atypical or complement-mediated HUS)

Differentiation of TTP from HUS can be confounded by kidney involvement in TTP.&nbsp;25% of patients with TTP had kidney injury&nbsp;in the Oklahoma TTP Registry.5,14,15

<h4>Variable presentation of TMAs, potential confusion with HUS, and lack of diagnostic protocols can result in a missed or delayed diagnosis of aTTP2,16</h4>

of patients with aTTP were misdiagnosed&nbsp;16&nbsp; 
 According to a retrospective review of the French Reference Centre for TMA registry (N=423).

This number may be underestimated due to the study being unable to exclude the possibility that some misdiagnosed patients may have died before their TTP diagnosis was made.16

<table align="center" border="0" cellpadding="1" cellspacing="1" style="width: 1000px;">
 <tbody>
 <tr>
 <td style="background-color: rgb(241, 135, 0); border-color: rgb(241, 135, 0);">
 The consequences of delayed diagnosis and treatment of TTP can be devastating, including organ failure or even death.7,11,15-17</td>
 </tr>
 </tbody>
</table>

aTTP=acquired thrombotic thrombocytopenic purpura; CBC=complete blood count; E coli=Escherichia coli; LDH=lactate dehydrogenase. *Emphasizes the regenerative nature of anemia. †Nonsystematic presence of schistocytes, possibly late onset, hence the importance of repeating this test several times to increase the sensitivity of the examination.16 ‡Test may turn out to be slightly positive in an autoimmune environment.16 §Related to hemolysis and organ tissue damage.6

References

<h2>How to diagnose thrombotic thrombocytopenic purpura (TTP)</h2>
<h3>Diagnosing TTP rapidly is critical and can save a life1</h3>
When a patient presents with2

<h4 style="text-align: center;">Severe thrombocytopenia</h4>
(often platelets &lt;30 × 109/L).

<h4 style="text-align: center;">Microangiopathic hemolytic anemia (MAHA)</h4>
characterized by the presence of schistocytes in blood smear

<h4 style="text-align: center;">With no identified cause</h4>

The risk of death is acute and imminent if TTP remains undiagnosed and untreated1,3,4

<h4 style="text-align: center;">of untreated patients1,3,4</h4>

<h4 style="text-align: center;">of the acute event if untreated1</h4>

<h3>Why TTP can be difficult to diagnose</h3>
TTP is rare and presents similarly to other thrombotic microangiopathies (TMAs), making it a challenge to diagnose. All TMAs result in thrombosis of capillaries and arterioles due to endothelial injury.5,6 
 A delay in diagnosing TTP can leave patients at risk for organ damage and death. The uncertainty around what’s happening to these patients can cause fear and frustration.5,7-9

<table align="center" border="0" cellpadding="1" cellspacing="1" style="width:1000px;">
 <tbody>
 <tr>
 <td style="background-color: rgb(241, 135, 0); border-color: rgb(241, 135, 0);">
 It's critical to differentiate TTP from other TMAs quickly so patients can get started on appropriate treatment</td>
 </tr>
 </tbody>
</table>
&nbsp;
<h2 style="text-align: center;">Diagnosing TTP in adults: Step-by-step1,7,10-15</h2>
Presentation

Headache and/or confusion and/or seizures and/or other cerebral abnormalities

Neurological symptoms

Abdominal pain, nausea, and diarrhea

Gastrointestinal symptoms

Chest pain and/or hypotension and/or myocardial infarction and/or congestive heart failure and/or sudden cardiac arrest and/or other cardiac abnormalities

Cardiac symptoms

Hematuria and proteinuria; creatinine &lt;2 mg/dL; typically not severe

Renal impairment

Diagnosing aTTP?

<h3 style="text-align: center;">Important TTP lab markers</h3>

The presence of schistocytes on the blood smear&nbsp;is the morphologic hallmark of the disease, but the absence of schistocytes does not rule out TTP.2,16

Although&nbsp;serum creatinine is typically &lt;2.0 mg/dL&nbsp;at presentation, the Oklahoma TTP-HUS Registry reported kidney injury 25% of the time.2,15

While not diagnostic,&nbsp;elevated LDH&nbsp;may be predictive of severe organ damage, and&nbsp;elevated troponin&nbsp;may indicate cardiovascular risk.1,2

ADAMTS13 activity &lt;10% confirms a TTP diagnosis&nbsp;and supports TTP treatment, but ADAMTS13 levels of 10% to 20% do not rule out TTP. TTP management will rely on clinical judgment.2,7,13

<table align="center" border="0" cellpadding="1" cellspacing="1" style="width:1000px;">
 <tbody>
 <tr>
 <td style="text-align: center; background-color: rgb(241, 135, 0); border-color: rgb(241, 135, 0);">
 ADAMTS13 &lt;10% confirms TTP. Test as soon as possible when TMA is suspected.2,7,13</td>
 </tr>
 </tbody>
</table>

LDH=lactose dehydrogenase; MAHA=microangiopathic hemolytic anemia; TMA=thrombotic microangiopathy; TTP=thrombotic thrombocytopenic purpura.

<h2>Guidelines for diagnosing and treating thrombotic thrombocytopenic purpura (TTP)</h2>

The International Society on Thrombosis and Haemostasis (ISTH) published guidelines are the first comprehensive, evidence-based, international guidelines on the diagnosis, treatment, and management of TTP.1

Most recent publication
The ISTH Guidelines for Diagnosis and Treatment were published July 2020.

About ISTH
With more than 5000 members across 100 countries, the ISTH is the leading thrombosis and hemostasis–related professional organization in the world.2

<h3>Why the ISTH Guidelines were developed</h3>
Diagnosing and treating TTP can be complicated.1
<ul>
 <li>The rarity of TTP—and its similar presentation to other TMAs—can make recognition a challenge info icon</li>
 <li>Management of TTP varies among healthcare professionals (HCPs)</li>
 <li>Treatment recommendations in TTP have evolved</li>
</ul>
<h3>ISTH created the guidelines as a comprehensive, uniform, international resource to inform the diagnosis and management of TTP1</h3>
The ISTH Guidelines can aid HCPs—both those with limited experience with TTP and those considered experts in TTP—in making a TTP diagnosis and following an appropriate treatment strategy.
These include1
<ul>
 <li>Emergency/critical care physicians</li>
 <li>Hematologists</li>
 <li>Nephrologists</li>
 <li>Neurologists</li>
 <li>Transfusion medicine specialists</li>
 <li>Hospitalists</li>
 <li>Policy makers</li>
</ul>

<table align="center" border="0" cellpadding="1" cellspacing="1" style="width:1000px;">
 <tbody>
 <tr>
 <td style="background-color: rgb(241, 135, 0); border-color: rgb(241, 135, 0);">
 The ISTH has created the first evidence-based guidelines to support rapid TTP diagnosis and treatment.</td>
 </tr>
 </tbody>
</table>

TTP is a life-threatening thrombotic microangiopathy (TMA) that requires quick diagnosis and urgent treatment. 1,2

Diagnosing TTP

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Latest Articles

Diagnosing aTTP

ISTH Guidelines

Diagnosing TTP