throbber
CLINICAL GUIDELINE
`Extravasation
`
`CG10058-7
`
`For use in (clinical areas):
`For use by (staff groups):
`For use for (patients):
`Document owner:
`Status:
`
`Oncology/Haematology Unit (excluding Paediatrics)
`Oncologists, Haematologists, Nursing Staff
`Oncology/Haematology patients receiving chemotherapy
`Cytotoxic User Group
`Approved
`
`Contents
`1. Purpose……………………………………………………………………………………..1
`2. Documentation……………………………………………………………………………..1
`3. Description………………………………………………………………………………….1
`4. References…………………………………………………………………………………9
`5. Cross-References………………………………………………………………………….10
`8. Development of the guideline…………………………………………………………….10
`
`1 Purpose
`1.1 To minimize the risk of permanent tissue damage by the quick effective management of
`suspected extravasation of cytotoxic drugs.
`
`2 Documentation
`The following documentation should be completed. Please refer to section 3.9 for further details.
`2.1 Nursing documentation
`2.2 Medical notes
`2.3 WSH NHS Trust Accident/Incident Book
`2.4 Extravasation report green card (in extravasation pack)
`2.5 WSH (NHS) Trust Extravasation Documentation Report
`
`3 Description
`
`3.1 General Principles
`3.1.1 Speed of diagnosis and prompt initiation of treatment is imperative in the effective
`management of vesicant extravasation of cytotoxic agents.
`
`Source: Cytotoxic User Group
`Status: Approved
`
`Issue Date: July 2011
`Valid until: July 2013
`
`Page 1 of 9
`
`Medac Exhibit 2024
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
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`

`

`West Suffolk Hospital NHS Trust
`
`CG10058-7
`Extravasation
`
`
`3.1.2 Extravasation of a vesicant drug should be treated as a medical emergency and treatment
`should ideally be initiated within 1 hour of the incident.
`3.1.3 All treatment interventions must be prescribed and administered by a Consultant or SpR.
`Under exceptional circumstances the prescribing can be delegated to another doctor and the
`administration to an agreed delegated person.
`3.1.4 Treatment will be dependant on the classification of the cytotoxic drug (see section 3.3).
`3.1.5 The patient’s Consultant must be informed of any extravasation of vesicant drugs. Out of
`hours the relevant on-call consultant should be informed
`3.1.6 All extravasations of vesicant drugs should be discussed with a plastic surgeon (see section
`3.6 and 3.7)
`3.1.7 If clinical judgment dictates alternative treatment to that described in this protocol full details
`of the rationale and the intervention should be documented in the patient’s notes.
`
`
`
`3.2 Diagnosis
`3.2.1 Extravasation refers to the accidental infiltration of a drug that has been administered via the
`intravascular route into surrounding subcutaneous tissues. It can be associated with extensive
`tissue damage.
`3.2.2 Extravasation should be suspected if a combination or all of the following symptoms occur:
`•
`Increased resistance when administering IV drugs
`• Lack of blood returned from the cannula/CVAD
`• Change in infusion quality, i.e. reduce flow rate
`• Any change in colour such as redness/blanching at the injection site
`• Swelling or oedema around the cannula
`• Pain or discomfort around the cannula site (stinging or burning)
`•
`Inflammation, erythema or blistering around the infusion site
`Note: Individually the above points are not diagnostic but in combination they may indicate
`extravasation.
`3.2.3 The degree of damage caused by extravasation relates to the amount of drug extravasated
`and the speed with which it is recognized and treated. Therefore drugs which are normally
`regarded as non vesicant should be treated as a vesicant if they have extravasated in large
`volumes e.g. 5-10mls.
`3.2.4 Delays in recognition and treatment can increase the risk of tissue necrosis.
`
`Source: Cytotoxic User Group
`Status: Approved
`
`
`Issue Date: July 2011
`Valid until: July 2013
`
`Page 2 of 9
`
`
`Page 00002
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`

`West Suffolk Hospital NHS Trust
`
`CG10058-7
`Extravasation
`
`
`3.3 Classification of Cytotoxic Drugs
`Drugs are classified in this protocol according to whether they are irritant, exfoliant, non-
`vesicant or vesicant. Treatment of vesicant extravasation is further classified as anthracycline or
`non-anthracycline.
`Vesicant: capable of causing pain, inflammation and blistering of the skin, underlying flesh and
`necrosis, leading to tissue death and necrosis.
`Exfoliant: capable of causing inflammation and shedding of the skin but less likely to cause tissue
`death.
`Irritants: capable of causing inflammation and irritation, rarely proceeding to breakdown of tissue.
`
`Drug
`Aclarubicin
`Actinomycin D
`(Dactinomycin)
`Alemtuzumab
`Amsacrine
`Arsenic
`Aspariginase
`Azacytidine
`Bevacizumab
`Bleomycin
`Bortezomib
`Busulfan
`Carboplatin
`Carmustine
`Cisplatin
`Cladribine
`Clofarabine
`Cyclophosphamide
`Cytarabine
`Cetuximab
`Dacarbazine
`Dactinomycin
`(Actinomycin D)
`Daunorubicin
`
`Classification
`Irritant/Exfoliant/Non Vesicant
`Vesicant
`
`Irritant/Exfoliant/Non Vesicant
`Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Vesicant
`Irritant/Exfoliant/Non Vesicant
`Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Vesicant
`Vesicant
`
`Vesicant anthracycline
`
`Treatment
`Cold compress
`Hyaluronidase and saline flush out
`
`Cold compress
`Hyaluronidase and saline flush out
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Hyaluronidase and saline flush out
`Cold compress
`Hyaluronidase and saline flush out
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Hyaluronidase and saline flush out
`Hyaluronidase and saline flush out
`
`Hyaluronidase and saline flush out +
`dexrazoxane
`Cold compress
`Hyaluronidase and saline flush out +
`dexrazoxane
`Hyaluronidase and saline flush out +
`dexrazoxane
`
`Docetaxel
`Doxorubicin
`
`Irritant/Exfoliant/Non Vesicant
`Vesicant anthracycline
`
`Epirubicin
`
`Vesicant anthracycline
`
`Source: Cytotoxic User Group
`Status: Approved
`
`
`Issue Date: July 2011
`Valid until: July 2013
`
`Page 3 of 9
`
`
`Page 00003
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`

`

`West Suffolk Hospital NHS Trust
`
`
`Etoposide
`Floxuridine
`Fludarabine
`Fluorouracil
`Gemcitabine
`Gemtuzumab
`Ozogamicin (Mylotarg)
`Idarubicin
`
`Ifosfamide
`Interleukin – 2
`Irinotecan
`Liposomal Daunorubicin
`Liposomal Doxorubicin
`(Adriamycin)
`Melphalan
`Methotrexate
`Mitomycin C
`Mitoxantrone
`Mylotarg (Gemtuzumab
`Ozogamicin)
`Oxaliplatin
`Paclitaxel
`Panitumumab
`Pegasparaginase
`Pemetrexed
`Raltitrexed
`Rituximab
`Streptozocin
`
`Teniposide
`Thiotepa
`
`Topotecan
`
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`
`Vesicant anthracycline
`
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Irritant/Exfoliant/Non Vesicant
`Vesicant
`Irritant/Exfoliant/Non Vesicant
`
`Irritant/Exfoliant/Non Vesicant
`
`Irritant/Exfoliant/Non Vesicant
`
`Trastuzumab
`
`Irritant/Exfoliant/Non Vesicant
`
`Treosulfan
`
`Vinblastine
`
`Vincristine
`Vindesine
`Vinorelbine
`
`
`
`Vesicant
`
`Vesicant
`
`Vesicant
`Vesicant
`Vesicant
`
`CG10058-7
`Extravasation
`
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`
`Hyaluronidase and saline flush out +
`dexrazoxane
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`
`Cold compress
`Cold compress
`Hyaluronidase and saline flush out
`Cold compress
`Cold compress
`
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Cold compress
`Hyaluronidase and saline flush out
`Cold compress
`
`Cold compress
`
`Cold compress
`
`Cold compress
`
`Hyaluronidase and saline flush out
`
`Hyaluronidase and saline flush out
`Hyaluronidase and saline flush out
`Hyaluronidase and saline flush out
`Hyaluronidase and saline flush out
`
`Source: Cytotoxic User Group
`Status: Approved
`
`
`Issue Date: July 2011
`Valid until: July 2013
`
`Page 4 of 9
`
`
`Page 00004
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`

`

`West Suffolk Hospital NHS Trust
`
`
`3.4 Treatment Intervention
`
`CG10058-7
`Extravasation
`
`3.4.1
`
`Use Table in section 3.3 to assess classification of drug and treat according to
`classification of drug and type of venous access.
`
`Extravasation Suspected
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Peripheral line
`
`
`Stop infusion/injection immediately
`DO NOT REMOVE CANNULA
`
`Disconnect Infusion
`
`
`
`
`
`Aspirate as much of the drug as possible from the cannula with a
`10ml syringe
`
`
`
`Collect the extravasation kit & inform SpR/consultant immediately
`of irritant/vesicant suspected extravasation
`
`
`
`Remove cannula and mark around area with pen
`
`
`
`
`Central Venous Access Device
`
`
`Stop infusion/injection immediately
`
`
`
`
`
`
`
`Aspirate drug from line
`
`
`
`Collect extravasation kit and inform SpR/consultant
`immediately of suspected irritant/vesicant extravasation
`
`
`Central line to remain in-situ
`Mark around area with a pen
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Elevate Limb
`
`
`
`SpR/consultant to prescribe treatment according to classification of drug (section 4.3) and inform responsible consultant (out of hours
`contact the West Suffolk consultant, if not available contact the consultant on-call at Addenbrookes)
`
`
`
`
`Irritant/ Exfoliant/ Non-Vesicants
`Vesicants (including vesicant anthracyclines)
`
`
`SpR/Oncologist/Haematologist to initiate treatment.
`
`
`
`
`
`
`
`Apply cold compress to affected area for 20 minutes, 4 times daily
`for 24 - 48 hours
`
`
`
`
`SpR/consultant or delegated person to undertake “Hyaluronidase
`and saline flush out” procedure under local anaesthetic (see
`section 3.5.)
`
`
`
`
`
` If drug is a vesicant anthracycline, Consultant Oncologist or
`Haematologist to prescribe Dexrazoxane (as per section 3.6). If
`Oncologist is not on the West Suffolk Hospital site, they will
`contact the Haematologist to assess patient and to prescribe
`Dexrazoxane if indicated
`
`
`
`
`
`
`
`
`Peripheral line
`
`
`
`Consultant to refer patient to Plastic
`Surgeon on-call for advice on further
`management and consideration of
`liposuction. See section 4.7
`
`
`
`CVAD
`
`
`
`Consultant to refer
`patient to Plastic
`Surgeon on call at
`Addenbrookes
`urgently for advice
`on further
`management
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Complete documentation:
`
`• West Suffolk Hospitals NHS Trust Incident Form
`•
`
`National Extravasation Reporting Scheme Green Card
`
`• Medical & nursing Documentation
`•
`
`Trust Extravasation Documentation Report
`
`Source: Cytotoxic User Group
`Status: Approved
`
`
`Issue Date: July 2011
`Valid until: July 2013
`
`Page 5 of 9
`
`
`Page 00005
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`

`

`West Suffolk Hospital NHS Trust
`
`
`
`
`CG10058-7
`Extravasation
`
`3.5 Hyaluranonidase and Saline Flush out Technique
`3.5.1 This should only be undertaken by a Consultant, SpR or agreed delegated person.
`3.5.2 Hyaluronidase is most effective if administered within 2 hours of the injury occurring, but still
`has benefits for up to 12 hours.
`3.5.3 Under aseptic conditions clean the site of injury and the immediate surrounding area.
`3.5.4 Reconstitute one or two 1500 unit vials of Hyaluronidase in 5-10mls of Lignocaine 1%.
`3.5.5 Infiltrate the subcutaneous layer of the area immediately under the site of extravasation.
`3.5.6 Using a scalpel make at least 4 small “incisions” into the subcutaneous layer-evenly spaced
`around the area to be treated.
`3.5.7 Insert the tip (without introducer) of a size 18/20g cannula, or 18g “drawing up needle” which
`is blunt, through one of the 4 incisions.
`3.5.8 Using a syringe attached to a three-way tap flush up to 1000ml of 0,9% sodium chloride in
`turn through each of the 4 incisions, as quickly as possible. If necessary apply pressure to the bag
`to ensure quick flow of fluid.
`3.5.9 If the area surrounding the extravasations becomes oedematous gently massage the area
`towards the nearest incision site to allow excess fluid to be removed. If necessary use an 18g
`“drawing up needle” which is blunt to make puncture sites for the fluid to escape.
`3.5.10 Once the procedure has been completed, dress the area with a layer of jelonet and gauze
`and elevate the limb for 24 hours.
`3.5.10.1 Consider prescription of prophylactic antibiotics (refer to trust antibiotic policy)
`3.5.10.2 The stab incisions should be allowed to close spontaneously and never be
`sutured.
`
`
`
`Source: Cytotoxic User Group
`Status: Approved
`
`
`Issue Date: July 2011
`Valid until: July 2013
`
`Page 6 of 9
`
`
`Page 00006
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`

`

`West Suffolk Hospital NHS Trust
`
`
`
`
`
`CG10058-7
`Extravasation
`
`3.6 Vesicant anthracycline extravasation and dexrazoxane
`3.6.1 Vesicant anthracyclines are associated with considerable morbidity when involved in
`extravasation incidents.
`3.6.2 In the event of vesicant anthracycline extravasation, the West Suffolk Plastic Surgeon to be
`contacted for advice. If he/she is not available then the on-call plastic surgeons at Addenbrookes
`should be consulted as a matter of urgency and they should be specifically informed that the
`extravasation involves a vesicant anthracycline. Hyaluronidase and saline flush out technique
`should be performed as per section 3.5. If the flush out involves no significant delay it should be
`carried out prior to the Dexrazoxane, otherwise commence the Dexrazoxane without delay.
`3.6.3 Ideally, the plastic surgeon will attend to make a baseline assessment. However, the
`administration of Dexrazoxane should not be delayed while waiting for their advice.
`3.6.4 Dexrazoxane must be prescribed by the Consultant Oncologist or Haematologist
`3.6.5 Dexrazoxane is administered into the unaffected arm daily for 3 days so appointments
`should be made for days 2 and 3 for administration of dexrazoxane and for assessment by plastic
`surgery.
`3.6.6 Following the 3 day administration of dexrazoxane, the plastic surgery team will advise on
`further management.
`
`
`
`3.7 Plastic Surgeon Review
`3.7.1 If the extravasation occurs via a peripheral line the West Suffolk Plastic Surgeon to be
`contacted for advice if he/she is not available then the on-call plastic surgeon at Addenbrookes
`should be contacted for advice.
`3.7.2 The patient should be referred urgently to the West Suffolk Plastic Surgeon if he/she is not
`available then the on call plastic surgeon at Addenbrookes if:
`• Drug extravasated via a CVAD
`• The skin is compromised
`• Extreme swelling
`• Significant extravasation
`• Skin necrosis
`
`
`
`
`3.8 Follow up
`3.8.1 The patient should be made aware that the site will remain sore for several days.
`3.8.2 Extravasation sites should be observed for pain, erythema, induration and necrosis and the
`findings recorded in the medical/nursing documentation.
`3.8.3 If the extravasation was caused by a vesicant drug appropriate arrangements should be
`made for follow up by the Oncologist/Haematologist or Plastic Surgeon.
`3.8.4 If the extravasation was caused by a non-vesicant drug the patient should be asked to report
`immediately any increase discomfort or significant change, i.e., peeling or blistering of the skin, to
`the Oncology Unit and a follow up appointment made.
`
`Source: Cytotoxic User Group
`Status: Approved
`
`
`Issue Date: July 2011
`Valid until: July 2013
`
`Page 7 of 9
`
`
`Page 00007
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`

`

`West Suffolk Hospital NHS Trust
`
`
`
`
`CG10058-7
`Extravasation
`
`3.9 Documentation
`3.9.1 The signs, symptoms, date and time of the injury should be recorded on a National
`Extravasation Reporting Scheme Green Card. In addition the following should be documented:
`• Time of review by medical staff
`• Referrals made
`• Arrangements for follow up appointments
`• Outcome of follow up assessments
`3.9.1.1 The National extravasation Reporting Scheme Green Card should be photocopied and
`filed in the patient’s notes as a permanent record of the assessment of the injury.
`3.9.1.2 The follow up report for the National Extravasation Reporting Scheme should be
`completed within 1 month following the incident
`3.9.2 The following information should be documented in the medical records
`• Time of review by medical staff
`• Referrals made (who & time)
`• Arrangements for subsequent follow up appointments required
`• Outcome of follow up assessments
`3.9.3 A West Suffolk Hospitals NHS Trust incident form should be completed.
`3.9.4 A Trust Extravasation Documentation should be completed and used for subsequent
`assessments
`
`
`4. References
`4.1 Dougherty L (1999) Safe handling and administration of intravenous cytotoxic drugs. In
`Dougherty L, Lamb J ( 1st ed) Intravenous therapy in nursing practice. Edinburgh: Churchill
`Livingstone. Chapter 16
`4.2 Allwood M, Stanley A, Wright P (2002) The Cytotoxics Handbook 4th ed. Radcliffe Medical
`Press. ISBN 1857775 504
`4.3 Gault D T (1993) Extravasation injuries. British Journal of Plastic Surgery March: 46 (2): 1991-
`1996.
`4.4 Stanfors B L & Hardwicke F. A Review of Clinical Experience with Paclitaxel Extravasations.
`Support Care Cancer (2003) 11: 270-277
`4.5 Mouridsen H.T. et al Ann Oncol doi:10.1093/annonc/mdl413
`
`
`5. Cross - References
`5.1 West Suffolk Hospital NHS Trust – Incident Reporting and Investigation Policy and Procedure
`5.2 West Suffolk Hospital NHS Trust –Prescription and Administration of Cytotoxic Drugs Policy
`and Procedure
`
`
`Source: Cytotoxic User Group
`Status: Approved
`
`
`Issue Date: July 2011
`Valid until: July 2013
`
`Page 8 of 9
`
`
`Page 00008
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`

`

`West Suffolk Hospital NHS Trust
`
`
`6. Development of the Guideline
`
`6.1 Changes compared to previous document
`This is an updated document, to reflect current knowledge and practice
`
`6.2 Statement of clinical evidence
`Refer to the reference list in the body of the document.
`
`CG10058-7
`Extravasation
`
`6.3 Contributors and peer review
`This guideline was updated and then circulated to the members of the WSH Cytotoxic Users
`Group for comment. Necessary amendments were then made.
`
`6.4 Distribution list/dissemination method
`The Haematologist, Oncologist & nursing staff in the Oncology/Haematology Unit are to receive
`paper copies of the guidelines. Awareness of this guideline will be promoted via staff meetings. It
`will be included in the educational sessions for new members of the nursing team as part of their
`chemotherapy administration assessment.
`
`
`6.5 Document configuration information
`
`
`Author(s):
`Other contributors:
`Approved by:
`
`Issue no:
`File name:
`Supercedes:
`Additional Information:
`
`WSH Cytotoxic Users Group
`WSH Cytotoxic Users Group
`WSH Cytotoxic Users Group
`WSH D&T Committee
`7
`CG 10058-7 Extravasation.doc
`6
`Changes made to include Dexrazoxane
`
`
`
`Source: Cytotoxic User Group
`Status: Approved
`
`
`Issue Date: July 2011
`Valid until: July 2013
`
`Page 9 of 9
`
`
`Page 00009
`
`

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