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Selected Investigations Completed April - September 1998 > Part II, Case no. E.1313/96-97

Part II - Full Texts of Selected Investigations

Case No. E.1313/96-97 - The clinical management of a dislocated elbow in a patient receiving anti-coagulants

Matters considered: Lack of priority given to correcting anti-coagulant state; diagnosis and treatment of internal bleeding

Complaint against: Southampton University Hospitals NHS Trust

Complaint as put by Mr X

1. The account of the complaint provided by Mr X was that in the morning of 5 June 1996 he was taken to the accident and emergency (A and E) department of Southampton General Hospital (the hospital), which is managed by Southampton University Hospitals NHS Trust (the Trust), after dislocating his left elbow. Mr X was receiving anti-coagulant (blood thinning) therapy so his wife, who accompanied him, took with her his anti-coagulation record book and warned staff of the danger that he might bleed profusely. At about 8.00pm Mr X was admitted to a ward, where his wife and daughter took steps to ensure that his damaged arm was elevated, to minimise the bleeding, as had been suggested by a doctor earlier in the day. While they were doing that, they noticed that blood had seeped through the dressing and that Mr X's arm was swollen. During the next three weeks he had several operations on his arm to relieve pressure caused by internal bleeding. He was left with impaired use of his fingers and thumb. Mr X's wife pursued a complaint through the NHS complaints procedure on his behalf, but he remained dissatisfied.

2. The complaint investigated was that the Trust's clinical management of Mr X's injury was unsatisfactory, in particular that:

1. insufficient priority was given to correcting his anti-coagulant state; and
2. insufficient steps were taken to diagnose and treat internal bleeding.

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Investigation

3. The statement of complaint for the investigation was issued on 18 August 1997. I obtained the comments of the Trust, and relevant papers were examined including Mr X's medical and nursing records for the relevant period. One of my investigators took evidence from Mr and Mrs X and from staff of the Trust. I appointed two independent professional assessors to provide clinical advice and their report is reproduced in paragraph 11.

Evidence of Mr and Mrs X

4. Mr X told my investigator that in the morning of 5 June 1996 he fell into a ditch in his garden and hurt his left arm. His wife wrapped up his arm and called for an ambulance, which took him to the A and E department of the hospital, arriving at about 10.30am. Mrs X had given the ambulance crew her husband's anti-coagulation record book and the ambulance crew gave it to staff of the A and E department. Mr X waited in a cubicle while his wife told a doctor that the situation was urgent because of her husband's anti-coagulant state. He was then taken for X-rays of his arm, before returning to the A and E cubicle. Another doctor came to see Mr X, and Mrs X again expressed concern about the potential for bleeding in her husband's arm. The doctor plastered the arm into position and said that it would be all right. Mr X then waited in the A and E cubicle until he was admitted to a ward. At about 9.00pm Mrs X became concerned about bleeding in her husband's arm, and she asked to see a doctor. A doctor came but took no action so Mrs X elevated the arm herself and then went home. No test was done on 5 June to establish Mr X's level of anti-coagulation.

5. The next morning there was extensive bruising to Mr X's shoulder and torso because of internal bleeding. Mrs X asked a nurse about Warfarin (the anti-coagulant therapy which her husband usually took daily) and was told that he had been given a dose that morning. Over the next three weeks Mr X had six operations on the arm, carried out by a number of different doctors. Mr and Mrs X thought that the anti-coagulant state was not regulated properly until a cardio-thoracic surgeon (who had inserted an artificial heart valve for Mr X in 1995) came to see him on 10 June.

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The Trust's response to the complaint

6. In the Trust's formal reply of 29 August 1997 at the start of my investigation, the chief executive wrote to my Office:

'The Trust ... accepts that communication was less than satisfactory and delays occurred in [Mr X] being transferred to the ward.'The Trust believes that medical staff in the [A and E] department were aware that [Mr X] was on Warfarin from his initial assessment, he was admitted to the ward as a result of this for further observation. Constant monitoring was undertaken and as concern grew, expert advice was sought. The medical team were faced with the need to take into consideration a number of medical issues relating to [Mr X's] condition and as such appropriate action was taken.'

7. An associate specialist in the A and E department (the associate specialist) told my investigator that he treated Mr X on 5 June. His entries in the medical records include:

'He is on Warfarin

'Clinically dislocated elbow

'[Advice] Admit for reduction under [general anaesthetic]'

8. The consultant in charge of the A and E department (the A and E consultant) said that it was his clinical opinion that Mr X's elbow dislocation had needed to be reduced as quickly as possible. He said that he would have been happier about the care given if the A and E staff had arranged a blood test at an early stage to ascertain Mr X's level of anti-coagulation. The Trust had no specific policy about patients on anti-coagulant therapy who attend the A and E department - clinical practice was to test the anti-coagulation of such patients if they had head injuries. He thought it would be appropriate to test the anti-coagulation of all trauma patients (that is, patients suffering from wounds or injuries) who were on anti-coagulant therapy. He added that the associate specialist's record of the joint reduction was inadequate, in that it did not make clear exactly what had happened and what had been prescribed. He suggested that the A and E department might introduce a form on which to record details of all surgical procedures undertaken, showing who did what and when, the drugs administered and any subsequent complications.

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9. The consultant orthopaedic surgeon who was responsible for Mr X's treatment as an inpatient (the orthopaedic consultant) told my investigator that 'it would have been a good idea' to have tested Mr X's anti-coagulation level on 5 June, but that there were no clinical indications of a need for a test at that time. (I have seen that the senior house officer who admitted Mr X to the ward noted in the medical records that he was taking Warfarin.) The orthopaedic consultant said that Mr X should have been admitted to the ward more quickly, but there was a backlog of patients to be admitted that day. He considered that monitoring of Mr X's arm could have been done more effectively in the ward than in the A and E department. Mr X's anti-coagulation level was tested on 6 June, the day after he was admitted, and was very high. The orthopaedic consultant had to consider whether it was safe to operate on the arm that day to reduce the pressure caused by internal bleeding. At about 8.30pm he decided that it was, and the operation took place at around midnight. To have operated sooner would have risked unstoppable bleeding. He thought it unlikely that any failure to elevate Mr X's arm would have been a key factor in the development of his subsequent problems. He believed that there had been an intra-neural bleed (that is, bleeding into the nerve) caused by the anti-coagulation.

10. The consultant cardio-thoracic surgeon who saw Mr X on 10 June said that the medical staff who dealt with Mr X had tried to control his anti-coagulation but had not fully succeeded.

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Professional Assessors' report

11. I reproduce next, in its entirety, the report prepared by the professional assessors whom I appointed to advise me about this complaint.

Report by the Professional Assessors to the Health Service Ombudsman

Professional Assessors:

The first assessor, MB BS BSc FRCS
Consultant Orthopaedic and Upper Limb Surgeon

The second assessor, MA MB BChir MD FRCP MRCPath
Consultant in Haemostasis and Thrombosis

Matters considered

Whether the clinical management of Mr X's injury was satisfactory, in particular with regard to correcting his anti-coagulant state and diagnosing and treating internal bleeding.

Basis of report

The following documents were made available to us by the Ombudsman's Office:

1. copies of Mr X's medical and nursing records for the period 5 June 1996 to 26 June 1996, including original X-ray films;
2. notes of interviews with Mr X and staff of the Trust conducted by the Ombudsman's investigator on 4 November 1997, and 9 and 19 January 1998. The first assessor attended, and participated in, the interviews with Trust clinicians on 9 January;
3. copies of correspondence between Mr and Mrs X, the Trust and the Ombudsman's Office; and
4. copies of internal Trust correspondence pertaining to the complaint.

Assessors' comments on the actions of medical staff

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Injury

Mr X was admitted to the A and E department of Southampton General Hospital on 5 June 1996. The casualty records indicate that he had fallen in a ditch sustaining an injury to the elbow. The records state that the elbow was swollen and clinically dislocated. They also indicate that Mr X had a normal pulse and that his sensation was intact with no evidence of any damage to the nerves or blood vessels. X-rays of the elbow were taken which show a posterior dislocation. We have had the opportunity to review these X-rays and are satisfied regarding the diagnosis.

At the time of his attendance at the hospital Mr X was taking Warfarin following the insertion of a mechanical heart valve.

Clinical Management in the A and E department

Mr X was reviewed in the A and E department by a clinical associate specialist who felt it appropriate that the dislocation of the elbow was reduced immediately. The records indicate that the reduction was carried out under Midazolam (sedation) and Morphine (strong pain relieving medication). Further X-rays were undertaken following the reduction, which show a satisfactory relocation of the joint. We have seen these X-rays and the joint is in a satisfactory position.

Although it was known that Mr X was on Warfarin therapy at the time he attended the A and E department, the blood test (called the INR - International Normalised Ratio) which is used to assess the degree of blood thinning by Warfarin - was not performed. We understand that there was no policy in the A and E department of this hospital routinely to check the INR of patients on Warfarin who attend with this type of injury.

Arrangements were made for Mr X to be admitted to hospital for observation following the emergency management of his orthopaedic injury.

Ongoing Clinical Events Following Admission to Hospital

The admitting junior doctor recorded in his notes that Mr X's left hand was to be observed regularly and also advised elevation of the arm. We are led to believe that this latter instruction was only performed at a later time following insistence by Mr X's wife and daughter.

The day following admission routine blood tests including an INR were performed. In addition the records indicate that assessment of Mr X's left arm nerves and blood vessels revealed no abnormality. Later that morning, however, Mr X developed evidence of bleeding into the tissues of his left arm. The results of his INR taken earlier that morning showed that his blood was very thin and at a level that was likely to have caused bleeding from blood vessels damaged by the original injury. He was given some fresh (blood) plasma, a conventional way of improving blood clotting, and the subsequent INR test showed that this was effective in partially correcting the blood thinning. A decision was taken by the orthopaedic surgeons not to return his blood clotting to normal (that is, an INR of 1) because of the possible risk of a blood clot forming around his mechanical heart valve.

Despite the measures taken to thicken his blood and local treatment to the arm including ice and elevation there was evidence that the bleeding was continuing and a decision was made to operate on the arm to remove the blood clot. This took place during the early hours of 7 June 1996. The operative findings confirmed the clinical diagnosis of bleeding within the arm. There was evidence of pressure on the nerves of the arm. A blood clot was removed with the expectation that the clinical situation would improve. Following this operation, a decision was made after discussion with a haematologist (a blood specialist) to maintain the blood thinning (INR) at a level of twice normal (that is, an INR of 2). This was to counterbalance the risk of further bleeding with that of a blood clot forming around the heart valve. However Mr X continued to have bleeding into the arm and a decision was made during the evening of 8 June 1996 that the blood thinning effect of his Warfarin should be reversed by the administration of the antidote vitamin K. It was also decided to replace the blood thinning effect of Warfarin with Heparin. This was performed in order to obtain greater control over his blood thinning.

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Despite the adjustment to Mr X's treatment further surgery was necessary on 9 June 1996. At operation a further large blood clot was removed. Post-operatively Mr X did not recover full nerve function and it was unclear whether this might be partly due to his pre-existing carpal tunnel syndrome (which causes pain or tingling in the fingers). For this reason the consultant orthopaedic surgeon advised further surgery to decompress the whole of the median nerve. The further surgical procedure was undertaken on 12 June 1996 and included decompression of the carpal tunnel. During this period Mr X was maintained on a low dose of Heparin anti-coagulation.

Conclusions

1. Initial orthopaedic management

The initial orthopaedic management in the A and E department appears appropriate and in keeping with what would be undertaken in any other A and E Department in the country. However the orthopaedic management undertaken by the associate specialist was poorly documented in the case records, and it was not clear from the records who had written them.

2. Anti-coagulant management

In our opinion Mr X should have had his INR checked in the A and E department at the time of his presentation, either by the A and E staff or the admitting orthopaedic doctors. The degree of blood thinning indicated by the INR measurement of the following day was at a level very likely to cause significant bleeding as a consequence of his injury. If this had been noted at the time of his presentation appropriate action could have been taken to reduce the degree of blood thinning which may have resulted in a decreased risk of the occurrence of bleeding. To minimise the risk of injury related bleeding it would have been desirable to return his blood thinning to normal. However this would have led to an increased risk of a blood clot forming around his mechanical heart valve. A decision therefore was subsequently taken to thin his blood to a level of twice normal. If this management had been instituted at the time of his admission he may have had a reduced degree of bleeding but it is not possible to determine whether trauma related bleeding would have been totally prevented.

3. Elevation of the left arm

As a general principle elevation of injured limbs helps to reduce swelling associated with soft tissue injury. In Mr X's case however there appears to have been a significant ongoing bleeding problem and we are uncertain whether such elevation would have materially affected the outcome had this been instituted at an earlier time.

4. Ongoing management

The decision to run his INR at a level of 2 is quite acceptable in this clinical situation and his subsequent anti-coagulant therapy achieved this up until the time his Warfarin was discontinued. Mr X's orthopaedic treatment following admission to hospital clearly indicates that he was kept under regular observation and that when deterioration in his condition occurred it was acted upon in a timely manner.

Assessors' Findings

Taking the two aspects of Mr X's complaint in turn we would like to make the following comments:

1. we are of the opinion that insufficient priority was given to correcting his anti-coagulant state at the time of his initial presentation to the A and E department of Southampton General Hospital by both A and E medical staff and the admitting orthopaedic doctors; and
2. we can find no evidence to suggest that insufficient steps were taken to diagnose the internal bleeding and in our opinion the subsequent treatment was satisfactory.

My findings

(a) Insufficient priority was given to correcting Mr X's anti-coagulant state

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12. On 5 June 1996, when Mr X dislocated his elbow, he was taking Warfarin because of the risk of blood clots forming around his mechanical heart valve. His wife gave his anti-coagulation record book to the ambulance crew who took him to hospital, and she made it clear to Trust staff that she was concerned about the potential for internal bleeding in his arm. The associate specialist who treated Mr X was aware of this, and noted it in the medical records. Similarly, the orthopaedic doctor who admitted him to the ward noted the fact that he was on Warfarin. Despite having this knowledge, none of the clinicians who treated Mr X on 5 June ordered an INR test of his anti-coagulant state. My professional assessors have stated that Mr X should have had his INR tested on 5 June, either by the A and E staff or the admitting orthopaedic doctors, and that if that had been done the clinicians could have acted to reduce the risk of excessive bleeding. They have stated also, however, that the subsequent decision to aim for an INR of 2 was acceptable. I agree with their views; I believe that insufficient priority was given to correcting Mr X's anti-coagulant state on 5 June - both by A and E staff and by the admitting orthopaedic team. I agree with the A and E consultant's view that it would normally be appropriate to test the INR of all trauma patients on anti-coagulant therapy who attend the A and E department; I recommend that the Trust do so.

13. The dislocation of Mr X's left elbow was diagnosed correctly by A and E staff, and my professional assessors have stated that the action of the associate specialist in reducing the joint as quickly as possible was appropriate - I endorse that view. They have remarked, however, that the records of the associate specialist's treatment were inadequate. I agree with them about this too. I recommend that the Trust take steps to ensure that clinical record keeping in the A and E department is improved and that those making entries in patients' records should sign their entries and write their names clearly. I note the A and E consultant's suggestion of a specific form for recording surgical details but I leave it to the Trust to decide how best to take this matter forward. I uphold the complaint.

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(b) Insufficient steps were taken to diagnose and treat internal bleeding

14. My professional assessors have noted in their report that evidence of internal bleeding developed late in the morning of 6 June. An INR test done that morning showed that Mr X's blood was very thin, making it likely that there would be bleeding from blood vessels damaged by the original injury. The clinicians acted to correct Mr X's anti-coagulation by giving him some fresh blood plasma, and a subsequent INR test showed that to have been partially effective. Despite this adjustment, however, and despite the use of ice and elevation of the arm, the bleeding continued. A blood clot was then removed from Mr X's arm early on 7 June but still the bleeding continued. On the evening of 8 June it was decided to reverse the anti-coagulant effect of the Warfarin by giving vitamin K, and changing from Warfarin to a low dose of Heparin. My assessors have said that although it would have been desirable to return Mr X's anti-coagulation level to normal in order to minimise the risk of bleeding that would have increased the risk of a blood clot forming around his mechanical heart valve. They concluded that the level of anti-coagulation at which he was kept was acceptable. Clearly, the clinicians had to compromise between minimizing the risks of excessive bleeding in the arm and the risks of clotting around the heart valve. My assessors found no evidence to support the assertion that insufficient steps were taken to diagnose internal bleeding, and they considered the treatment to have been satisfactory. They were unable to judge whether additional elevation of Mr X's arm would have affected the outcome. I do not uphold the complaint.

Conclusion

15. It is understandable that Mr X was dissatisfied with the outcome of his treatment - he was left with continuing pain and loss of function in his arm. Had the medical staff given priority to his anti-coagulation level from the time of his arrival at the hospital, they might have reduced his anti-coagulation more quickly and he might have suffered less internal bleeding and required fewer operations. I criticise the staff involved for that omission, but I have found no evidence of any other failings in the medical care.

16. I have set out my findings in paragraphs 12 to 14. The Trust have accepted my recommendations in paragraphs 12 and 13 and have asked me to convey to Mr X - as I do through this report - their apologies for the shortcomings I have identified.

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Last updated: 12 January 2006