International Society on Thrombosis and Haemostasis bleeding scale
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Overview
The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
ISTH Definitions of Bleeding
Major bleeding has been used as a primary endpoint for the evaluation of safety in clinical trials. The ISTH definitions of major bleeding in non-surgical and surgical patients are as follows:
Major Bleeding in Non-Surgical Patients[1]
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1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. |
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Major Bleeding in Surgical Patients[2]
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1. Fatal bleeding. and/or 2. Bleeding that is symptomatic and occurs in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, pericardial, in a non-operated joint, or intramuscular with compartment syndrome, assessed in consultation with the surgeon. and/or 3. Extrasurgical site bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells, with temporal association within 24–48 h to the bleeding. and/or 4. Surgical site bleeding that requires a second intervention (open, arthroscopic, endovascular) or a hemarthrosis of sufficient size as to interfere with rehabilitation by delaying mobilization or delayed wound healing, resulting in prolonged hospitalization or a deep wound infection. and/or 5. Surgical site bleeding that is unexpected and prolonged and/ or sufficiently large to cause hemodynamic instability, as assessed by the surgeon. There should be an associate fall in hemoglobin level of at least 2 g/dL (1.24 mmol/L), or transfusion, indicated by the bleeding, of at least two units of whole blood or red cells, with temporal association within 24 h to the bleeding. 6. The period for collection of these data is from start of surgery until five half-lives after the last dose of the drug with the longest half-life and with the longest treatment period (in case of unequal active treatment durations). 7. The population is those who have received at least one dose of the study drug. |
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Minor Bleeding
All non-major bleeds will be considered minor bleeds. Minor bleeds will be further divided into those that are clinically relevant and those that are not.
Clinically Relevant Minor Bleed
A clinically relevant minor bleed is an acute or subacute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following:
- A hospital admission for bleeding, or
- A physician guided medical or surgical treatment for bleeding, or
- A change in antithrombotic therapy (including interruption or discontinuation of study drug).
ISTH/SSC Bleeding Score
The ISTH/SSC proposed a bleeding assessment tool to standardize the reporting of bleeding symptoms in both pediatric and adult populations. It facilitates the diagnosis of less symptomatic mild bleeding disorder and the grading of severity in patients with known inherited bleeding disorders. For each specific bleeding symptom, a score of 1 or more is classified as significant. Scores and descriptions of bleeding symptoms are as follows:[3]
| Symptoms | Score | ||||
| 0 | 1 | 2 | 3 | 4 | |
| Epistaxis | No/trivial | >5 year or more than 10 mintues | Consultation only | Packing or cauterization or antifibrinolytic | Blood transfusion or replacement therapy (use of hemostatic blood components and rFVIIa) or desmopressin |
| Cutaneous | No/trivial | For bruises 5 or more (>1 cm) in exposed areas | Consultation only | Extensive | Spontaneous hematoma requiring blood transfusion |
| Minor wounds | No/trivial | >5 year or more than 10 mintues | Consultation only | Surgical hemostasis | Blood transfusion, replacement therapy, or desmopressin |
| Oral cavity | No/trivial | Present | Consultation only | Surgical hemostasis or antifibrinolytic | Blood transfusion, replacement therapy or desmopressin |
| GI bleeding | No/trivial | Present (not associated with ulcer, portal hypertension, hemorrhoids, angiodysplasia) | Consultation only | Surgical hemostasis, antifibrinolytic | Blood transfusion, replacement therapy or desmopressin |
| Hematuria | No/trivial | Present (macroscopic) | Consultation only | Surgical hemostasis, iron therapy | Blood transfusion, replacement therapy or desmopressin |
| Tooth extraction | No/trivial or none done | Reported in ≤25% of all procedures, no intervention | Reported in >25% of all procedures, no intervention | Resuturing or packing | Blood transfusion, replacement therapy or desmopressin |
| Surgery | No/trivial or none done | Reported in ≤25% of all procedures, no intervention | Reported in >25% of all procedures, no intervention | Surgical hemostasis or antifibrinolytic | Blood transfusion, replacement therapy or desmopressin |
| Menorrhagia | No/trivial | Consultation only or Changing pads more frequently than every 2 hours or Clot and flooding or PBAC score >100 | Time off work/school >2/year or Requiring antifibrinolytics or hormonal or iron therapy | Requiring combined treatment with antifibrinolytics and hormonal therapy or Present since menarche and > 12 months | Acute menorrhagia requiring hospital admission and emergency treatment or Requiring blood transfusion, Replacement therapy, Desmopressin or Requiring dilatation & curretage or endometrial ablation or hysterectomy) |
| Post-partum hemorrhage | No/trivial or no deliveries | Consultation only or Use of syntocin or Lochia > 6 weeks | Iron therapy or Antifibrinolytics | Requiring blood transfusion, replacement therapy, desmopressin or Requiring examination under anaesthesia and/or the use of uterin balloon/package to tamponade the uterus | Any procedure requiring critical care or surgical intervention (e.g. hysterectomy, internal iliac artery legation, uterine artery embolization, uterine brace sutures) |
| Muscle hematomas | Never | Post trauma, no therapy | Spontaneous, no therapy | Spontaneous or traumatic, requiring desmopressin or replacement therapy | Spontaneous or traumatic, requiring surgical intervention or blood transfusion |
| Hemarthrosis | Never | Post trauma, no therapy | Spontaneous, no therapy | Spontaneous or traumatic, requiring desmopressin or replacement therapy | Spontaneous or traumatic, requiring surgical intervention or blood transfusion |
| CNS bleeding | Never | — | — | Subdural, any intervention | Intracerebral, any intervention |
| Other bleedings | No/trivial | Present | Consultation only | Surgical hemostasis, antifibrinolytics | Blood transfusion or replacement therapy or desmopressin |
References
- ↑ Schulman, S.; Kearon, C. (2005). "Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients". J Thromb Haemost. 3 (4): 692–4. doi:10.1111/j.1538-7836.2005.01204.x. PMID 15842354. Unknown parameter
|month=ignored (help) - ↑ Schulman, S.; Angerås, U.; Bergqvist, D.; Eriksson, B.; Lassen, MR.; Fisher, W. (2010). "Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients". J Thromb Haemost. 8 (1): 202–4. doi:10.1111/j.1538-7836.2009.03678.x. PMID 19878532. Unknown parameter
|month=ignored (help) - ↑ Rodeghiero, F.; Tosetto, A.; Abshire, T.; Arnold, DM.; Coller, B.; James, P.; Neunert, C.; Lillicrap, D. (2010). "ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders". J Thromb Haemost. 8 (9): 2063–5. doi:10.1111/j.1538-7836.2010.03975.x. PMID 20626619. Unknown parameter
|month=ignored (help)