| PGD DETAILS |
| Tranexamic Acid- Patients with time critical injury where significant haemorrhage is suspected Valid from 14/01/2025Review date 01/06/2026Expiry date 31/12/2027 |
| Version Control- Record of Amendments | |
| January 2025 | Introduction of new PGD- version 1.0 |
| RATIONALE FOR PATIENT GROUP DIRECTIONS (PGDs) | |
| Eligible Healthcare Professional | Only healthcare professionals specified in the PGD (e.g., registered nurses, paramedics) who have completed the required training and are authorized may administer this medication. Unauthorized administration is prohibited and may result in disciplinary or legal consequences. Always adhere to PGD guidelines to ensure patient safety and compliance. Registered Paramedic [ü] Registered Nurse [ü] |
| Qualifications and Professional Registration | Current registration with the HCPC as a Paramedic. Current registration with the NMC as an Advanced Nurse Practitioner |
| Training and Competency | All registered healthcare professionals are personally accountable for their practice and in the exercise of professional accountability. There is a requirement to demonstrate and maintain competence in the following before undertaking administration under this PGDAn understanding of professional standards for the administration of medicinesFamiliarity with the local policies and procedures relating to medicines. Appropriate training to carry out the clinical assessment of a patient.Basic training in the legal framework and use of PGDs for the supply and administration of medicinesUnderstanding of pharmacology of drugs being administered to patients and relevant medical condition. |
| Continued Training and Competency | The clinician must meet the requirements of the prevailing level of education required for PGD use at this level of practice.All ongoing regular training requirements (e.g. statutory and mandatory training) as required by the company for this role must be completed. The clinician is responsible for keeping themself aware of any changes to the recommendations for the medicine listed. It is the responsibility of the individual to keep up to date with continued professional development and to work within the limitations of their own individual scope of practice.This PGD should be read in conjunction with JRCALC Guidelines |
| CLINICAL CONDITION | |
| Indication: | Patients of all ages with signs of actual or suspected severe haemorrhage in the following clinical scenarios:Patients triggering local network major trauma criteriaPatients with a time-critical injury where significant internal or external haemorrhage is known or suspectedPost-partum haemorrhage if after administration of an uterotonic drug the patient continues to bleedPatients over 18 with head injury with a Glasgow Coma Score (GCS) of 12 or lessBleeding due to disorders of an obstetric nature |
| Inclusion Criteria: | TraumaTreatment of known or suspected severe traumatic internal & external haemorrhage (other than gastrointestinal haemorrhage) as soon as clinically possible on arrival at the scene and within 3 hours of bleeding starting in adults or children – this maybe demonstrated by one or more of the following:Systolic pressure less than 90mmHg or absent radial pulse or heart rate greater than 110bpm in adultsIn children this maybe demonstrated by physiological parameters age appropriate as per JRCALCAny patient where haemostatic gauze or dressings, tourniquet(s) or chest / pressure dressings have been appliedPatients who have suffered traumatic cardiac arrestPost-partum haemorrhagePPH (bleeding from the genital tract >500ml) which usually occurs within 4 hours (but up to 24 hours) after delivery. This can be associated with haemodynamic instability. Tranexamic acid should be given after the administration of a uterotonic drug (misoprostol / syntometrine) except in individuals for whom uterotonic drugs are contraindicated (rare). Women with a post-partum haemorrhage when uterine trauma (rupture) is suspected. Bleeding may be intra-abdominal.Head Injury Tranexamic acid should be administered to any patient aged 18 years and over, who have a known or suspected head injury with a GCS of 12 or less, where the injury has occurred within the last 3 hours |
| Exclusion Criteria /Contra-indications: | Known previous reaction to tranexamic acidBleeding greater than 3 hoursObvious resolution of haemorrhageKnown or suspected gastrointestinal haemorrhageIsolated head injuryPost-partum haemorrhage before administration of uteronic drugCritical interventions required e.g. traumatic dressings and or haemorrhage control devicesManufacturer’s list of Contraindications:https://www.medicines.org.uk/emc/product/3374/smpc/print#CONTRAINDICATIONS |
| Cautions: | Contact on-call Known history of convulsionsKnown history of acute venous or arterial thrombosisSevere renal impairmentRapid injection may cause hypotension and loss of consciousnessDo not administer through the same line as blood products Individuals with a known history of renal impairment, acute venous or arterial thrombosis- in the low dose regime recommended here, the benefit from giving tranexamic acid for severe hemorrhage outweighs the risk. This information should be passed to the receiving hospital. Pregnancy and Breastfeeding:Tranexamic acid has been subject to some controlled clinical studies in pregnancy. Tranexamic acid does cross the placenta, but the effect on the baby is unknown. There is no evidence of teratogenicity in animal studies. The benefits of administration must outweigh any potential risk.Manufacturer’s Information:https://www.medicines.org.uk/emc/product/3374/smpc/print#PREGNANCYTranexamic acid’s safe use during lactation has not been established. There is a small amount present in breast milk, although any anti-fibrinolytic effect in the infant is unlikely. The benefits of administration must outweigh any potential risk. |
| Drug Interactions | Individuals receiving oral contraceptives may have an increased risk of thrombosis. In the low dose regime recommended here, the benefit from giving tranexamic acid for severe haemorrhage outweighs the risk of thrombotic events. If known that the individual is currently taking an oral contraceptive this information should be passed to the receiving hospital.A detailed list of drug interactions is available in the BNF or SPC, which is available from the electronic Medicines Compendium website: https://www.medicines.org.uk/emc/product/3374/smpc#INTERACTIONS |
| Action if patient declines or is excluded: | Continue other treatment as appropriate, transfer to receiving hospital department or nearest appropriate Emergency Department.Follow JRCALC and local service procedure.Document on PRF:-Intended actions by the patientDetails of any referral madeCapacity of patient to decline treatment |
| DRUG DETAILS | |
| Name, form and strength of medication covered under this PGD: | Tranexamic Acid containing 100mg/ml in 5ml (500mg) or 10ml (1000mg) ampoules |
| Legal Category | Prescription Only medicine (POM) |
| Storage | All preparations should be stored within manufacturers labelled guidelines and should not exceed 25 degrees C |
| Indicate any off-label use (if relevant) | Best practice advice is given by JRCALC and is used for guidance in this PGD and this may vary from the Summary of Product Characteristics (SPC).The use of tranexamic acid in severe haemorrhage following trauma and in head injury is off label. However its use is supported by national JRCALC guidelines.The use of tranexamic acid in children under 1 year of age is off label, however its use is supported by national JRCALC guidelines.Intraosseous route is supported by JRCALC guidance. |
| Route/Method: | Intravenous IV / Intraosseous IOThis should be administered slowly over 10 minutes- can be given as 10 aliquots administered 1 minute apart |
| Dosage: | Traumatic Haemorrhage and Post Partum HaemmorhageAdults and children over 12 years- 1 gram 11yrs: 500 Milligrams 10yrs: 500 Milligrams 9yrs: 450 Milligrams 8yrs: 400 Milligrams 7yrs: 350 Milligrams 6yrs: 300 Milligrams 5yrs: 300 Milligrams 4yrs: 250 Milligrams 3yrs: 200 Milligrams 2yrs: 200 Milligrams Children > 9months: 150 Milligrams 9 months 150 Milligrams 6 months 100 Milligrams3 months 100 Milligrams 1 month 50 Milligrams Birth 50 milligramsPost-partum haemorrhage in women – A second dose can be administered if bleeding continues after 30 minutes of the first dose being administered. Any further doses are not permissible within 24 hours |
| Frequency: | As detailed in above schedule |
| Duration of Treatment: | One episode of care only |
| Maximum or Minimum Treatment Period: | As detailed above |
| Quantity to Administer | As Dosage above. This medication should be administered in sight of attending Clinician. Staff are not permitted to provide medications to be taken at a later date. |
| Side Effects: | NauseaVomitingDiarrhoeaHypersensitivityHypotension if administered rapidlyEmbolism at administration sites |
| Advice to Patient/Carer: | Advise on the effects this may have on the patient.When administering Tranexamic Acid, the patient should have the treatment and the course of treatment explained including any adverse effects, In addition they should be informed that they will be transferred to the nearest and most appropriate Emergency Department for further treatment.The individual/parent/carer should be advised to seek medical advice in the event of an adverse reaction |
| Management of Adverse Reactions | The practitioner acting under this PGD must ensure that all necessary drugs and equipment are available for immediate treatment should a hypersensitivity reaction occur and must be trained to manage anaphylaxis and/or support ventilation. Healthcare professionals and individuals/carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme; 08081003352 or on: http://yellowcard.mhra.gov.uk |
| REFERAL ARRANGEMENTS & DOCUMENTATION | |
| Referral Arrangements: | As per local arrangements/national guidelines |
| Records/Audit Trail: | Patients name, address, date of birth and consent given.Contact details of GP (If registered)DiagnosisDose and form administeredBatch and expiry date detailsAdvice given to patient (including side effects)Signature/name of staff who administered or supplied medication, and also, if relevant, signature/name of staff who removed/discontinued the treatmentDetails of any adverse drug reaction and actions taken including documentation in the patients’ medical record. Usage documented on PRF & drug Administration book |
| References/ Resources and Comments: | Electronic BNF https://bnf.nice.org.uk/drug/tranexamic-acid.htmlElectronic Medicines Compendium http://www.medicines.org.uk/NICE NG 39: Major trauma: assessment and initial management. https://www.nice.org.uk/guidance/ng39Manufacturer’s Information https://www.medicines.org.uk/emc/product/3374/smpcPatient Leaflet pil.3374.pdf (medicines.org.uk)JRCALC guideline https://www.jrcalc.org.uk/NICE Medicines practice guideline “Patient Group Directions” https://www.nice.org.uk/guidance/mpg2CRASH 2 trial https://www.thelancet.com/crash-2All accessed January 2025 |
| PGD DEVELOPMENT AND AUTHORISATION | ||
| ORGANISATION | Coast Medic Ambulance Ltd | |
| MEDICAL DIRECTOR | Name: | Dr Rhys Owens |
| Signature: | | |
| Date: | 14.01.2025 | |
| PHARMACIST | Name: | Neil Hayward |
| Signature: | ||
| Date: | 14.01.2025 | |
| CHIEF EXECUTIVE | Name: | Luke Tudor |
| Signature: | | |
| Date: | 14.01.2025 |
| Individual Authorisation | |||
| Name: | Signature: | Authorising Manager: | Date: |