Robert Goodman

9th March 2021 

Dear Mr Pegg 

Chief Nursing Officer 
Trust HQ 
C Level, Centre Block, Mailpoint 14 
Southampton General Hospital 
Tremona Road 
Southampton, SO16 6YD 

Tel: 

Email : 

Please  find  below  our  response  to  your  Regulation  28:  Report  to  Prevent  Future  Deaths  which  you 
issued on the 15th December 2020. As you aware, the Trust was unfortunately not informed that you 
had issued this report at the time and was only sent a copy on 12th January 2021.  

Your concerns: 

When found on the floor the deceased stated that he had a head injury. The Trust has a policy for the 
assessment and early management of head injuries. The policy was, on the evidence, drafted in 2016. 
The Trust policy is said to reflect the National Institute for Health and Care Excellence guidance on the 
assessment  and  early  management  of  head  injuries.  The  deceased  was  receiving  the  anticoagulant 
enoxaparin whilst in hospital. The present Trust policy states that a computerised tomography scan of 
the  head  should  be  undertaken  within  8  hours  of  the  injury  if  a  patient  is  receiving  anticoagulant 
treatment. The evidence suggested that enoxaparin is a “low dose anticoagulant” which did not place 
the  deceased  within  the  Trust  policy  where  a  computerised  tomography  scan  should  be  provided 
within 8 hours of a head injury. The Trust were not aware of the September 2019 variation in National 
Institute  for  Health  and  Care  Excellence  guidance  which  now  advises  that  patients  who  are  on  any 
anticoagulant  should  have  a  computerised  tomography  scan  within  8  hours  of  a  head  injury.  The 
Trust’s policy does not presently reflect the National Institute for Health and Care Excellence revised 
guidance, in place since September 2019. It was accepted in evidence that the deceased would have 
had a computerised tomography scan within 8 hours of a head injury if the revised National Institute 
for  Health  and  Care  Excellence  guidance  had  been  applied  and  reflected  in  the  Trust  policy.  The 
deceased’s computerised tomography scan was undertaken 30 hours after the deceased had suffered 
a head injury 

Our response: 

Firstly, I would like to reassure you that the Trust has a procedure in place for ensuring that all NICE 
guidance  is  reviewed  on  publication  and  that  all  relevant  Trust  policies  and  procedures  are 
subsequently updated, where appropriate.  

On  investigation,  it  is  not  clear  why  the  Trust’s  policy  was  not  updated  following  the  publication  of 
Clinical Guideline [CG176], in September 2019. However, I can assure you that this does appear to be 
an  isolated  incident.  Furthermore,  the  Trust  has  satisfied  itself  that  its  procedure  for  checking  NICE 
guidance and updating its internal policies and procedures in a timely way is robust. 

In  respect  of  NICE  Clinical  Guideline  [CG176],  I  can  confirm  that  the  Trust’s  policy  has  now  been 
amended so that it is clear that patients receiving therapeutic anticoagulant treatment including Direct 
Oral Anticoagulants (DOACs) should undergo a CT scan within 8 hours of a suspected head injury.  

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 The Trust launched the updated policy on the 26th January 2021, our head of patient safety e mailed 
out to the clinical teams (including consultants, nursing, pharmacy and therapy staff) to notify them of 
the updated policy and highlight the key changes including the NICE guidance. We  also included the 
updated policy on the clinical updates section on our staff intranet.  

There has been a great deal of discussion between my clinical colleagues as to whether patients who 
are receiving a prophylactic dose of say Enoxaparin would also require a CT scan within 8 hours of a 
suspected head injury given that the NICE guidelines appear to specifically relate to therapeutic doses 
of DOAC’s, Warfarin etc. 

Enoxaparin is widely used in the hospital environment at a prophylactic dose for prevention of Venous 
Thromboembolic  disease.  This  dose  is  effective  at  reducing  thromboembolic  disease  by  up  to  70%. 
However, it is not sufficient in order to result in the levels of anticoagulation required for proven DVTs, 
PEs or for acute ischaemic events to develop.  

This  is  evidenced  in  the  medical  literature  which  seem  to  show  a  difference  in  the  bleeding  risk 
between  prophylactic  and  treatment  doses.  For  example,  the  Electronic  Medicines  Compendium 
Clexane pre-filled syringes - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk) 
states, 

 “At  doses  used  for  prophylaxis  of  venous  thromboembolism,  enoxaparin  sodium  does  not  influence 
bleeding time and global blood coagulation tests significantly, nor does it affect platelet aggregation or 
binding of fibrinogen to platelets.”  

In relation to treatment specifically given to the elderly, it goes on to state,  

“No  increased  bleeding  tendency  is  observed  in  the  elderly  with  the  prophylactic  dosage  ranges. 
Elderly  patients  (especially  patients  eighty  years  of  age  and  older)  may  be  at  an  increased  risk  for 
bleeding complications with the therapeutic dosage ranges.”  

On the basis of the current medical literature on the subject, patients who are receiving a prophylactic 
dose of Enoxaparin are not routinely given a CT scan following a fall unless they are exhibiting clinical 
signs that are suggestive of a bleed.   

The consensus opinion among Medicine for Older People colleagues is that providing a CT scan for all 
patients  on  a  prophylactic  dose  of  enoxaparin,  without  other  clinical  signs  and  symptoms  being 
evident, would not influence the outcomes for those patients. However, it could overwhelm a hospital’s 
scanning  capacity,  meaning  that  there  is  a  risk  that  other  patients,  who  do  require  a  CT  scan,  may 
face a delay in obtaining this to the potential detriment of their health.  

Unfortunately, NICE’s Clinical Guideline [CG176] fails to provide specific guidance on this point. We, 
therefore,  contacted  the  National  Falls  Lead  at  NHSE/I  who  confirmed  that  “we  are  aware  that 
concordance with the guidelines by acute providers is problematic”. We understand that there is to be 
a  full  review  of  the  evidence,  undertaken  by  NICE,  in  order  to  clarify  whether  prophylactic 
anticoagulants should trigger the same requirements as therapeutic doses of DOACs and Warfarin.  

this 

scope  of 

The 
found  at  https://www.nice.org.uk/guidance/GID-
NG10164/documents/draft-scope  We  note  that  the  issue  of  prophylactic  anticoagulants  does  not 
appear to be specifically referred to although NICE should be able to confirm to you whether they are 
considering this as part of their review.  

can  be 

review, 

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 We  have  also  contacted  the  Falls  Special  Interest  Group  Lead  in  the  British  Geriatric  Society  to 
highlight  this  omission  in  NICE  guidance  not  least  so  that  a consensus  approach can  be  developed 
nationally for these patients in the meantime.  

Finally,  I  would  like  to  assure  you  that,  whilst  further  guidance  from  NICE  is  awaited,  the  Trust  will 
continue to ensure that all patients receiving a prophylactic dose of Enoxaparin, who develop clinical 
signs and symptoms following a fall, will undergo a CT scan within 8 hours of a suspected head injury 
in addition to all those patients who have received a therapeutic dose of DOAC’s, Warfarin etc. 

Yours sincerely, 

Chief Nursing Officer 

cc.  

CEO  
 Inspection Manager, Care Quality Commission  

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