assessing and correcting for bleeding risk prior to invasive procedures (ISTH 2021, bsh 2023, bsh 2024)

summary chart

See this one page BSH 2023 interventional procedure bleeding risk guidance

procedure-related bleeding risk

Approach to defining high risk procedures

Risk of a particular procedure causing bleeding, i.e. Risk of major bleeding >1.5% = High Risk
Ease of diagnosing/controlling any bleeding that occurs (e.g. retroperitoneum)
Potential consequences of any bleeding that occurs (e.g. spinal procedures)
Complexity of the procedure (e.g. normally low risk procedure but w/ anatomical complexities)
Patient complexity - Age, Hypertension, Renal Failure, Obesity, Infection, Haematocrit

Operator-related factors

More experienced operators have lower rates of bleeding complications
Ultrasound-guidance reduces number of punctures and reduces bleeding complications

Other specific procedures considered high risk

Percutaneous solid organ puncture
Deep intra-abdominal drainage or biopsy
Arteriography requiring >7 French catheters (e.g. aortoiliac interventions)
Transjugular intrahepatic portosystemic shunts (TIPSS)
Thoracic venous interventions

patient-related bleeding history

Screening Questionnaires

Historically, standardised bleeding scores, e.g. ISTH BAT, were developed and validated to detected inherited bleeding disorders (usually VWD).

HEMSTOP is specifically for perioperative assessment, to identify patients with bleeding symptoms.

Several caveats to the HEMSTOP study (discussed in the BSH2024 guideline)

Score >2 = est. positive predictive value 39% for a patient-related bleeding risk requiring special precautions
Score <2 = est. negative predictive value >99% for a patient-related bleeding risk requiring special precautions

HEMSTOP Questionnaire

To be used for all patients not on anti-thrombotic therapy, one point for each ‘yes’:

Have you ever consulted a doctor or received treatment for prolonged or unusual bleeding?
Do you experience bruises/haematomas larger than 2cm without trauma, or severe bruising after minor trauma?
After a tooth extraction, have you ever experienced prolonged bleeding requiring medical/dental consultation?
Have you experienced excessive bleeding during or after surgery?
Is there anyone in your family who suffers from a bleeding disorder?
Have you ever consulted a doctor or received treatment for heavy or prolonged menstrual periods?
Did you experience prolonged or excessive bleeding after delivery?

Anti-thrombotic medications

General Points

All patients on antiplatelets/anticoagulants should be counselled about the risks of pre-procedural bleeding/thrombosis

3x increase in major cardiac events in patients discontinuing aspirin (when used as secondary prophylaxis) prior to invasive procedure (meta-analysis 2006). But absolute risk likely remains <1% in most scenarios.

Most low risk procedures can be performed without holding anticoagulants and aspirin.

BSH 2024 Recommendations for elective procedures

Aspirin: Continue unless high risk
Clopidogrel: Omit for 5-7 days
Dual antiplatelet therapy: Discuss with cardiology.
Prasugrel: Omit for 7 days, and discuss with cardiology
Ticagrelor: Omit for 3-5 days, and discuss with cardiology
Dipyridamole: Omit on day of procedure
LMWH prophylaxis: Last dose >12 hours prior to procedure
LMWH treatment: Last dose >24 hours prior to procedure
UFH: Omit for 4-6 hours
Agatroban/Bivalirudin: Omit for >4 hours
Fondaparinux prophylaxis: Omit for 1-2 days
Fondaparinux treatment: Omit for 3+ days
Warfarin: Omit for 5 days + check INR pre-procedure
DOAC: Omit for 2 days unless low risk procedure

coagulation testing & Prophylactic plasma products

Key Message

Do not perform routine coagulation testing prior to elective surgical procedures (see rationale below)

This also true of platelet function tests (w/ possible exceptions for antiplatelets & cardiac surgery)
Use of TEG/ROTEM pre-procedure is currently a research tool only (as of 2024)

FFP

There is no benefit to the use of prophylactic FFP in non-bleeding patients with abnormal clotting tests

FFP usually fails even to correct the abnormal clotting time, never mind clinical benefits

Fibrinogen replacement

No evidence to support specific FGN levels prior to invasive procedures

BSH2024 recommends replacement should be considered if FGN <1.0g/l in an unwell, hospitalised patient

This can be with cryoprecipitate or fibrinogen concentrate

Rationale for avoiding unselected coag testing

Practical consequences

Delays procedure/surgery
Anxiety for patients
False reassurance to surgeon
Expensive and uses up lab time

‘Normal Range’ = 2 SD above and below the mean in disease-free subjects.

—> Therefore, 2.5% of disease-free subjects will have an abnormal result

Result may be normal in patients at risk of bleeding

E.g. Some APTT reagents only sensitive to FVIII <30 iu/dL —> will miss mild haem A / VWD
PT/APTT may be normal in patients taking direct oral anticoagulants

Result maybe abnormal in a healthy patient

E.g. FXII deficiency, Lupus Anticoagulant

Platelet Transfusion

General Points

There is no high quality evidence quantifying bleeding risk according to platelet count in invasive procedures

Transfusion 2017 - 18,000 patients undergoing interventional radiology - Prophylactic platelet transfusion in patients with plt <50 did not reduce bleeding, improve clinical outcomes or reduce the use of red cell transfusion.

Pre-procedure testing of platelet count

Low risk procedures: Not recommended prior to low risk procedures
- Due to lack of any evidence for benefit
- One exception: Haematological conditions known to cause thrombocytopenia
High risk procedures: Check an up-to-date platelet count prior to high risk procedures

Pre-procedure platelet thresholds

See recommendations on platelet page

special populations

Liver Disease

See ISTH guideline notes below
BSH2024 specifically recommends against correcting thrombocytopenia or clotting times prior to:
- Diagnostic OGD +/- variceal ligation
- TOE
- Paracentesis
- Thoracocentesis
- PICC insertion
- CVC catheter exchange or removal
- Dental procedures including extractions
- Skin biopsy
Vitamin K replacement is not recommended pre-procedure for patient with cirrhosis. It does not significantly affect clotting times in cirrhosis and there is no evidence to support its use.
TPO agonists can be considered 9-14 days prior to elective procedures but may have thrombotic side effects, including portal vein thrombosis. Although they increase platelet count, the clinical effect on bleeding risk is uncertain.

Critical Care

Up to 30% of ITU have an INR >1.5 at some point during admission
Up to 60% thrombocytopenic on transfer to ITU, up to 44% develop whilst on ITU
There is a lack of evidence to prophylactic correct this numbers prior to common ITU procedures

Preventing procedural bleeding in liver cirrhosis (ISTH 2021)

Intro

Prophylactic correction of abnormal clotting tests / platelet counts prior to procedures in patients with cirrhosis is common, but this practice is not supported by the available evidence.

‘Rebalanced haemostasis’ refers to the observations that despite the correlation between the degree of derangement of clotting studies with the disease severity of the cirrhosis, this does not automatically lead to an increased bleeding risk. E.g.

Low coagulation factors affect PT/APTT, but liver-derived anticoagulant factors will also be low
Low platelet counts but elevated VWF levels
Low fibrinolytic and antifibrinolytic factors

This is supported by results of global tests of haemostasis which have shown hypercoaguable states in chronic and acutely decompensated cirrhosis.

Patient Factors affecting bleeding risk

Anticoagulants, antiplatelets
Infection
Anaemia
Renal failure
Portal hypertension
?Bleeding history - careful when taking, consider whether bleeding pre-dates the cirrhosis.

Procedural Factors affecting bleeding risk

Estimated risk of a particular procedure causing bleeding
Ease of controlling any bleeding that occurs
Potential consequences of any bleeding that occurs
Guideline contains a table listing procedures and their bleeding risk

Management

PT/INR/APTT/Platelet count should not be used routinely to predict bleeding risk pre-procedure, therefore:

Prophylactic correction of abnormal clotting tests count not advised
Prophylactic platelet count correction for patients with a plt count >30 only advised for very high risk surgeries (Platelet count <30 = consider alternative causes to liver disease)

Review modifiable risk factors for bleeding - drugs, infection, renal impairment

?Vitamin K - single dose of 10mg may correct prolonged PT/APTT. Repeated doses not indicated

?Tranexamic acid - no studies in this setting. Consider as an intervention if bleeding occurs

?TPO agonists - Avatrombopag and Lusutrombopag approved for chronic liver disease prior to invasive procedures. Maximum rise in platelet count occurs approx. day 12. Meta-analysis has confirmed efficacy on raising platelet count, but less clear whether this actually leads to reduced procedure-related bleeding.