Grading of bleeding symptoms at presentation and at each subsequent evaluation
| Type of bleeding . | Grade based on the worst incident episode since last visit* . | ||||
|---|---|---|---|---|---|
| 0 . | 1 . | 2 . | 3 . | 4 . | |
| Skin | |||||
| Petechiae (does not include steroid-induced or senile purpura) | [ ] No | [ ] Less than or equal to 10 in a patient's palm-sized area† in the most affected body area‡ | [ ] More than 10 in a patient's palm-sized area or more than 5 in at least 2 patient's palm-sized areas located in at least 2 different body areas,‡ one above and one below the belt (in the most affected body areas) | [ ] More than 50, if scattered both above and below the belt | |
| [ ] Any number if reported by the patient | |||||
| Ecchymoses | [ ] None or up to 2 in the same body area,‡ but smaller than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§ | [ ] 3 or more in the same body area,‡ but all smaller than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§ | [ ] From 1 to 5 larger than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§with or without smaller ones | [ ] More than 5 larger than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§ | |
| [ ] At least 2 in two different body areas,‡ smaller than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§ | |||||
| [ ] Any number and size if reported by the patient | |||||
| Subcutaneous hematomas | [ ] No | [ ] 1 smaller than a patient's palm-sized area | [ ] 2 smaller than a patient's palm-sized area, spontaneous | [ ] More than 2 smaller or at least 1 larger than a patient's palm-sized area, spontaneous | |
| [ ] Any number and size if reported by the patient | [ ] 2 smaller than a patient's palm-sized area, disproportionate to trauma§ | [ ] More than 2 smaller or at least 1 larger than a patient's palm-sized area, disproportionate to trauma§ | |||
| Bleeding from minor wounds|| | [ ] No | [ ] Lasting ≤5 min | [ ] Lasting >5 min or interfering with daily activities | [ ] Requiring protracted medical observation at the time of this visit | |
| [ ] Any episode if reported by the patient | [ ] Medical report describing patient's evaluation by a physician | ||||
| Mucosa | |||||
| Epistaxis¶ | [ ] No | [ ] Lasting ≤5 min | [ ] Lasting >5 min or interfering with daily activities | [ ] Packing or cauterization or in-hospital evaluation at the time of this visit | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] Any episode if reported by the patient | [ ] Medical report describing packing or cauterization or in-hospital evaluation | ||||
| Oral cavity, gum bleeding¶ | [ ] No | [ ] Lasting ≤5 min | [ ] Lasting >5 min or interfering with daily activities | [ ] Requiring protracted medical observation at the time of this visit | |
| [ ] Any episode if reported by the patient | [ ] Medical report describing patient's evaluation by a physician | ||||
| Oral cavity, hemorrhagic bullae or blisters | [ ] No | [ ] Less than 3 | [ ] From 3 to 10 but no difficulty with mastication | [ ] More than 10 or more than 5 if difficulty with mastication | |
| [ ] Any number if reported by the patient | |||||
| Oral cavity, bleeding from bites to lips and tongue or after deciduous tooth loss | [ ] No | [ ] Lasting ≤5 min | [ ] Lasting >5 min or interfering with daily activities | [ ] Interventions to ensure hemostasis or in-hospital evaluation at the time of this visit | |
| [ ] Any episode if reported by the patient | [ ] Medical report describing interventions to ensure hemostasis or in-hospital evaluation | ||||
| Subconjunctival hemorrhage (not due to conjunctival disease) | [ ] No | [ ] Petechiae/ hemorrhage partially involving 1 eye | [ ] Petechiae/ hemorrhage partially involving both eyes, or diffuse hemorrhage in 1 eye | [ ] Diffuse hemorrhage in both eyes | |
| [ ] Any episode if reported by the patient | |||||
| Organ (and internal mucosae) | |||||
| GI bleeding not explained by visible mucosal bleeding or lesion: hematemesis, melena, hematochezia, rectorrhagia | [ ] No | [ ] Any episode if reported by the patient | [ ] Present at the visit | [ ] Requiring endoscopy#or other therapeutic procedures or in-hospital evaluation at the time of this visit | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] Described in a medical report | [ ] Medical report prescribing endoscopy# or other therapeutic procedures or in-hospital evaluation | ||||
| Lung bleeding | [ ] No | [ ] Any episode if reported by the patient | [ ] Present at this visit | [ ] Requiring bronchoscopy# or other therapeutic procedures or in-hospital evaluation at the time of this visit | [ ] RBC transfusion or Hb drop >2 g/dL |
| Hemoptysis | [ ] Described in a medical report | [ ] An equivalent episode if described in a medical report | |||
| Tracheobronchial bleeding | [ ] Medical report exhibited by the patient prescribing endoscopy or other procedures or in-hospital evaluation | ||||
| Hematuria | [ ] No | [ ] Any episode if reported by the patient | [ ] Macroscopic | [ ] Macroscopic, and requiring cystoscopy# or other therapeutic procedures or in-hospital evaluation at the time of this visit | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] Microscopic (laboratory analysis) | [ ] Described in a medical report | [ ] An equivalent episode if described in a medical report | |||
| Menorrhagia (compared with pre-ITP or to a phase of disease with normal platelet count)** | [ ] No | [ ] Doubling number of pads or tampons in last cycle compared with pre-ITP or to a phase of disease with normal platelet count | [ ] Changing pads more frequently than every 2 h or clot and flooding | [ ] Acute menorrhagia requiring hospital admission or endometrial ablation (either at this visit or described in a medical report) | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] Score >100 using PBAC in the last cycle, if normal score in pre-ITP cycles or in a phase of disease with normal platelet count | [ ] Requiring combined treatment with antifibrinolytics and hormonal therapy or gynecologic investigation (either at this visit or described in a medical report) | ||||
| Intramuscular hematomas (only if diagnosed by a physician with an objective method) | [ ] No | [ ] Post trauma, diagnosed at this visit, if judged disproportionate to trauma | [ ] Spontaneous, diagnosed at this visit | [ ] Spontaneous or post trauma (if judged disproportionate to trauma) diagnosed at this visit and requiring hospital admission or surgical intervention, | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | |||
| Hemarthrosis (only if diagnosed by a physician with an objective method) | [ ] No | [ ] Post trauma, diagnosed at this visit, function conserved or minimally impaired, if judged disproportionate to trauma | [ ] Spontaneous, diagnosed at this visit, function conserved or minimally impaired | [ ] Spontaneous or post trauma (if judged disproportionate to trauma), diagnosed at this visit and requiring immobilization or joint aspiration | [ ] Spontaneous or post trauma (if judged disproportionate to trauma) diagnosed at this visit and requiring surgical intervention |
| [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | ||
| Ocular bleeding (only if diagnosed by a physician with an objective method) | [ ] No | [ ] Any post trauma vitreous or retinal hemorrhage involving one or both eyes with or without impaired/blurred vision present at this visit if judged disproportionate to trauma | [ ] Spontaneous vitreous or retinal hemorrhage involving one or both eyes with impaired/blurred vision present at this visit | [ ] Spontaneous vitreous or retinal hemorrhage with loss of vision in one or both eyes present at this visit | |
| [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | |||
| Intracranial bleeding††: intracerebral, intraventricular, subarachnoidal, subdural, extradural (only if diagnosed with an objective method at the visit or described in a medical report provided by the patient) | [ ] No | [ ] Any post trauma event requiring hospitalization | [ ] Any spontaneous event requiring hospitalization in the presence of an underlying intracranial lesion | [ ] Any spontaneous event requiring hospitalization without an underlying intracranial lesion | |
| Other internal bleeding: hemoperitoneum, hemopericardium, hemothorax, retroperitoneal bleeding, hepatic and splenic peliosis with organ rupture, retro-orbital bleeding metrorrhagia (only if diagnosed with an objective method at the visit or described in a medical report provided by the patient) | [ ] No | [ ] Any event requiring hospitalization <48 h | [ ] Any event requiring hospitalization >48 h or RBC transfusion or Hb drop >2 g/dL | ||
| Type of bleeding . | Grade based on the worst incident episode since last visit* . | ||||
|---|---|---|---|---|---|
| 0 . | 1 . | 2 . | 3 . | 4 . | |
| Skin | |||||
| Petechiae (does not include steroid-induced or senile purpura) | [ ] No | [ ] Less than or equal to 10 in a patient's palm-sized area† in the most affected body area‡ | [ ] More than 10 in a patient's palm-sized area or more than 5 in at least 2 patient's palm-sized areas located in at least 2 different body areas,‡ one above and one below the belt (in the most affected body areas) | [ ] More than 50, if scattered both above and below the belt | |
| [ ] Any number if reported by the patient | |||||
| Ecchymoses | [ ] None or up to 2 in the same body area,‡ but smaller than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§ | [ ] 3 or more in the same body area,‡ but all smaller than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§ | [ ] From 1 to 5 larger than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§with or without smaller ones | [ ] More than 5 larger than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§ | |
| [ ] At least 2 in two different body areas,‡ smaller than a patient's palm-sized area, if (a) spontaneous or (b) disproportionate to trauma/constriction§ | |||||
| [ ] Any number and size if reported by the patient | |||||
| Subcutaneous hematomas | [ ] No | [ ] 1 smaller than a patient's palm-sized area | [ ] 2 smaller than a patient's palm-sized area, spontaneous | [ ] More than 2 smaller or at least 1 larger than a patient's palm-sized area, spontaneous | |
| [ ] Any number and size if reported by the patient | [ ] 2 smaller than a patient's palm-sized area, disproportionate to trauma§ | [ ] More than 2 smaller or at least 1 larger than a patient's palm-sized area, disproportionate to trauma§ | |||
| Bleeding from minor wounds|| | [ ] No | [ ] Lasting ≤5 min | [ ] Lasting >5 min or interfering with daily activities | [ ] Requiring protracted medical observation at the time of this visit | |
| [ ] Any episode if reported by the patient | [ ] Medical report describing patient's evaluation by a physician | ||||
| Mucosa | |||||
| Epistaxis¶ | [ ] No | [ ] Lasting ≤5 min | [ ] Lasting >5 min or interfering with daily activities | [ ] Packing or cauterization or in-hospital evaluation at the time of this visit | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] Any episode if reported by the patient | [ ] Medical report describing packing or cauterization or in-hospital evaluation | ||||
| Oral cavity, gum bleeding¶ | [ ] No | [ ] Lasting ≤5 min | [ ] Lasting >5 min or interfering with daily activities | [ ] Requiring protracted medical observation at the time of this visit | |
| [ ] Any episode if reported by the patient | [ ] Medical report describing patient's evaluation by a physician | ||||
| Oral cavity, hemorrhagic bullae or blisters | [ ] No | [ ] Less than 3 | [ ] From 3 to 10 but no difficulty with mastication | [ ] More than 10 or more than 5 if difficulty with mastication | |
| [ ] Any number if reported by the patient | |||||
| Oral cavity, bleeding from bites to lips and tongue or after deciduous tooth loss | [ ] No | [ ] Lasting ≤5 min | [ ] Lasting >5 min or interfering with daily activities | [ ] Interventions to ensure hemostasis or in-hospital evaluation at the time of this visit | |
| [ ] Any episode if reported by the patient | [ ] Medical report describing interventions to ensure hemostasis or in-hospital evaluation | ||||
| Subconjunctival hemorrhage (not due to conjunctival disease) | [ ] No | [ ] Petechiae/ hemorrhage partially involving 1 eye | [ ] Petechiae/ hemorrhage partially involving both eyes, or diffuse hemorrhage in 1 eye | [ ] Diffuse hemorrhage in both eyes | |
| [ ] Any episode if reported by the patient | |||||
| Organ (and internal mucosae) | |||||
| GI bleeding not explained by visible mucosal bleeding or lesion: hematemesis, melena, hematochezia, rectorrhagia | [ ] No | [ ] Any episode if reported by the patient | [ ] Present at the visit | [ ] Requiring endoscopy#or other therapeutic procedures or in-hospital evaluation at the time of this visit | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] Described in a medical report | [ ] Medical report prescribing endoscopy# or other therapeutic procedures or in-hospital evaluation | ||||
| Lung bleeding | [ ] No | [ ] Any episode if reported by the patient | [ ] Present at this visit | [ ] Requiring bronchoscopy# or other therapeutic procedures or in-hospital evaluation at the time of this visit | [ ] RBC transfusion or Hb drop >2 g/dL |
| Hemoptysis | [ ] Described in a medical report | [ ] An equivalent episode if described in a medical report | |||
| Tracheobronchial bleeding | [ ] Medical report exhibited by the patient prescribing endoscopy or other procedures or in-hospital evaluation | ||||
| Hematuria | [ ] No | [ ] Any episode if reported by the patient | [ ] Macroscopic | [ ] Macroscopic, and requiring cystoscopy# or other therapeutic procedures or in-hospital evaluation at the time of this visit | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] Microscopic (laboratory analysis) | [ ] Described in a medical report | [ ] An equivalent episode if described in a medical report | |||
| Menorrhagia (compared with pre-ITP or to a phase of disease with normal platelet count)** | [ ] No | [ ] Doubling number of pads or tampons in last cycle compared with pre-ITP or to a phase of disease with normal platelet count | [ ] Changing pads more frequently than every 2 h or clot and flooding | [ ] Acute menorrhagia requiring hospital admission or endometrial ablation (either at this visit or described in a medical report) | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] Score >100 using PBAC in the last cycle, if normal score in pre-ITP cycles or in a phase of disease with normal platelet count | [ ] Requiring combined treatment with antifibrinolytics and hormonal therapy or gynecologic investigation (either at this visit or described in a medical report) | ||||
| Intramuscular hematomas (only if diagnosed by a physician with an objective method) | [ ] No | [ ] Post trauma, diagnosed at this visit, if judged disproportionate to trauma | [ ] Spontaneous, diagnosed at this visit | [ ] Spontaneous or post trauma (if judged disproportionate to trauma) diagnosed at this visit and requiring hospital admission or surgical intervention, | [ ] RBC transfusion or Hb drop >2 g/dL |
| [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | |||
| Hemarthrosis (only if diagnosed by a physician with an objective method) | [ ] No | [ ] Post trauma, diagnosed at this visit, function conserved or minimally impaired, if judged disproportionate to trauma | [ ] Spontaneous, diagnosed at this visit, function conserved or minimally impaired | [ ] Spontaneous or post trauma (if judged disproportionate to trauma), diagnosed at this visit and requiring immobilization or joint aspiration | [ ] Spontaneous or post trauma (if judged disproportionate to trauma) diagnosed at this visit and requiring surgical intervention |
| [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | ||
| Ocular bleeding (only if diagnosed by a physician with an objective method) | [ ] No | [ ] Any post trauma vitreous or retinal hemorrhage involving one or both eyes with or without impaired/blurred vision present at this visit if judged disproportionate to trauma | [ ] Spontaneous vitreous or retinal hemorrhage involving one or both eyes with impaired/blurred vision present at this visit | [ ] Spontaneous vitreous or retinal hemorrhage with loss of vision in one or both eyes present at this visit | |
| [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | [ ] An equivalent episode if described in a medical report | |||
| Intracranial bleeding††: intracerebral, intraventricular, subarachnoidal, subdural, extradural (only if diagnosed with an objective method at the visit or described in a medical report provided by the patient) | [ ] No | [ ] Any post trauma event requiring hospitalization | [ ] Any spontaneous event requiring hospitalization in the presence of an underlying intracranial lesion | [ ] Any spontaneous event requiring hospitalization without an underlying intracranial lesion | |
| Other internal bleeding: hemoperitoneum, hemopericardium, hemothorax, retroperitoneal bleeding, hepatic and splenic peliosis with organ rupture, retro-orbital bleeding metrorrhagia (only if diagnosed with an objective method at the visit or described in a medical report provided by the patient) | [ ] No | [ ] Any event requiring hospitalization <48 h | [ ] Any event requiring hospitalization >48 h or RBC transfusion or Hb drop >2 g/dL | ||
Grading is based on physical examination at the time of the visit by the physician or expert nurse or on patient’s history supplemented by available medical reports. Bleeding manifestations reported by the patient but not visible at the time of data collection are graded 1. Grade 5 is assigned to fatal bleeding. In addition to the guidance offered in the table, refer to supplemental Appendix 3 for more detailed definitions and to the data collection form in supplemental Appendix 4. Illustrative examples are available on the website of the Hematology Project Foundation (http://itpbat.fondazioneematologia.it/). To receive a grade >1, all nonovert skin and nonovert mucosal bleeding (petechiae, ecchymoses, subcutaneous hematomas, vesicles, bullae, subconjunctival bleeding) should be visible at the time of visit for grading by the physician or expert nurse taking the history. For bleeding from minor wounds and overt mucosal bleeding (epistaxis, gum, bleeding from bites to lips and tongue, or after deciduous tooth loss/extraction) and all organ bleeding, a medical record describing the symptom or indicating a specific intervention/prescription should also be taken into account for grading. Requirement for ITP-specific treatments and antifibrinolytics (apart from menorrhagia) were not considered for grading because of their subjective nature and their adoption to control actual bleeding and to reduce the risk of impendent or future bleeding (see supplemental Appendix 1). In the case of patients examined for the first time, all types of bleeding occurring at the visit and in the 15 days preceding the visit should be considered.
GI, gastrointestinal; Hb, hemoglobin; PBAC, Pictorial Blood Assessment Chart (see supplemental Appendix 3); RBC. red blood cell;
Each type of bleeding should be graded on the basis of the worst bleeding manifestation that occurred during each observation period or in the 15 days preceding the first visit.
Patient’s own palm size is commonly considered to be proportional to body surface area. Palm, the inner surface of the hand stretching between the distal crease of the wrist and the bases of the fingers (fingers’ surface excluded).
Body areas include face, neck, right and left upper limbs (considered separately), right and left lower limbs (considered separately), trunk, abdomen, and recumbent areas (for the ambulatory patient, it means the area below the knees).
Bleedings considered proportionate to trauma/constriction on a clinical ground should not be reported for skin domain.
Minor wound means superficial skin cuts (eg, by shaving razor, knife, or scissors).
Epistaxis and gum bleeding are also reported in some normal subjects. Thus, a critical judgment is required in grading these manifestations; they should be reported only if judged more severe when compared with pre-ITP bleeding, if any.
Any endoscopic investigations should be considered for grading only if performed for therapeutic purpose and not solely for diagnostic purpose.
In girls at menarche, grade 1 cannot be assigned, lacking comparison with previous cycles.
Intracranial bleeding should always be reported, irrespective of its grade. For example, if a woman had S2 (subcutaneous hematoma) M2 (epistaxis) O3 (menorrhagia) and an intracranial bleeding grade 2 (post trauma, requiring hospitalization), the SMOG index is S2M2O3 intracranial 2. If the same patient also had intracranial bleeding grade 3, the SMOG index is S2M2O3 (intracranial 3) (see paragraph Refinement of the SMOG index).