Effectiveness of autologous fibrin tissue adhesive in reducing postoperative blood loss during total hip arthroplasty: a prospective randomised study of 100 cases

INTRODUCTION

Total hip arthroplasty (THA) is associated with a considerable amount of perioperative blood loss ranging from 700 ml to 1700 ml,1- 4 and blood transfusion is often required. Methods of blood conservation are sought to minimise the risks associated with transfusion of homologous blood, including transfusion reactions and the transmission of viral diseases such as human immunodeficiency virus,5 hepatitis,6,7 and cytomegalovirus.8,9 These methods include preoperative haemodilution,10 preoperative autologous blood donation,4,11-15 hypotensive anaesthesia,16 and intra-operative and postoperative blood salvage and reinfusion.17,18

An alternative approach is to use fibrin tissue adhesive (FTA) as a haemostatic agent during surgery.19,20 Despite its extensive use in other specialties,21-23 FTA is not widely used in orthopaedic surgery. Commercial FTA products carry a potential risk of infection because they are manufactured from pooled human plasma and are expensive for routine use.

Preoperative autologous blood donation is commonly performed in patients undergoing THA to avoid homologous transfusion. Preparation of FTA from autologous blood does not require special instruments and is cost-effective.24-25 During total joint replacement surgery, 10 ml of FTA (obtained from 400 ml of precionated blood) is usually used. This prospective randomised study aimed to evaluate the effectiveness and safety of autologous FTA (auto-FTA) obtained from 400 ml of precionated autologous blood in patients undergoing THA.

MATERIALS AND METHODS

From September 2000 to August 2001 inclusive, in 220 patients at the Saga University Hospital, 250 THAs were performed. The ethics committee of the hospital approved this investigation and informed consent was obtained from each patient prior to enrolment in the study. All male patients or patients with bleeding diathesis, or on anticoagulant therapy or haemodialysis, or with revision THA, femoral osteotomy, dislocated hip, ankylosed hip, or haemoglobin concentration of <100 g/l were also excluded. A total of 100 patients were recruited. Using a computer-generated randomisation list, 50 were assigned to receive treatment with FTA (auto-FTA group) and 50 to treatment without FTA (control group). A single senior surgeon performed all the operations, using a cementless prosthesis (Kyocera AMS cup, PerFix stem, HWMPH liner, 26-mm head). During surgery and just prior to the possible application of the auto-FTA, the surgeon was notified via a study monitor whether the patient was to receive FTA treatment. This was to minimise the possibility of bias that would occur if the surgeon deviated from standard haemostatic techniques and practices because of prior knowledge about which study group the patient was in.

All patients donated 400 ml of blood (for autologous transfusion) 3 weeks prior to surgery. Patients then received oral iron supplements (200 mg ferrous fumarate) for 3 weeks. Erythropoietin products were not administered. The auto-FTA was prepared as previously reported24: the whole blood was centrifuged, separated plasma was collected and stored at -40

Surgery was performed on all patients under spinal anaesthesia in a complete lateral position. The posterolateral approach and cementless THA were used. The auto-FTA was sprayed into the proximal femoral canal after rasping, and around the stem-collar after the stem was inserted to seal the canal (Fig. 1). A drain was placed in the joint and was connected to a high-vacuum suction unit. Intra-operative blood loss was evaluated by measuring the volume in the suction apparatus and by estimating the amount of lost blood in the swabs. Postoperative blood loss was recorded by measuring the volume of blood in the suction drain and the gauze drain at hour 1, 6, 12, 24, and 48. Total postoperative blood loss was evaluated for 48 hours. All patients were transfused with 400 ml of autologous blood on the day of surgery. No anti-thrombotic therapy was prescribed postoperatively.

The 2 groups were compared with regard to age, weight, haemoglobin value before donation and perioperative laboratory data, namely, red blood cell count, haemoglobin concentration, haematocrit, platelet count, prothrombin time, activated partial thromboplastin time, and fibrinogen level. The haemoglobin concentration was measured on postoperative day 1.

The occurrences of complications such as infection, deep vein thrombosis, or pulmonary embolism were recorded. Patients were followed up for 3 years to evaluate the rate of bone ingrowth or heterotopic ossification.

Demographic data and other baseline parameters were analysed to ascertain the comparability of the 2 study groups. Efficacy was evaluated by determining the significance of differences in the results between the 2 groups. The two-sample t test and the nonparametric Mann-Whitney U test were used to compare the 2 groups. A probability value of p<0.05 was considered significant.

RESULTS

No significant differences were observed between the 2 groups with regard to age, weight, preoperative haemoglobin concentration, and bleeding parameters (Table 1) or mean operating time and intra-operative blood loss (Table 2).

The mean postoperative blood loss at hour 1, 24, and 48 in the auto-FTA group was significantly less than that in the control group (p<0.001). The mean postoperative blood loss at 48 hours was 580 ml (range, 133-1290 ml) in the auto-FTA group and 810 ml (range, 155-1811 ml) in the control group; this difference (230 ml) was statistically significant (p<0.001).

The mean postoperative decrease in haemoglobin concentration at day 1 was 17 g/1 (range, 6-40 g/l) in the auto-FTA group and 22 g/l (range, 1-47 g/l) in the controls; this difference (5 g/l) was statistically significant (p=0.03, Table 2).

The percentage of patients with total blood loss of >1200 ml was significantly lower in the auto-FTA than control group, based on cross tables and Chi squared test (p=0.01). Only 2 (4%) of the patients in the auto-FTA group had postoperative blood loss of >1200 ml, compared to 10 (20%) in the control group (Fig. 2).

No patient in either group required homologous transfusion or developed major complications such as infection, severe deep vein thrombosis, or pulmonary embolism. No significant differences were observed between the 2 groups in the rate of bone ingrowth and heterotopic ossification at their 3-year follow-up.

DISCUSSION

The present study is the first controlled study of patients undergoing cementless THA with au to-FTA treatment. To minimise variability and reduce bias, the study population was restricted to female patients, since they are less likely to have infra-operative complications and extensive blood loss. The differences in the mean postoperative blood loss at 48 hours and mean decrease in haemoglobin concentration at day 1 were similar to those of a previous study that used commercial FTA to reduce postoperative bleeding in THA.21 The efficacy of FTA treatment in reducing the extent of blood loss was slightly lower in the present study. This may be attributed to the standardisation of the patient population and the surgical procedure. Thus, greater benefit from FTA treatment may be gained by males than females.21 To standardise the intra-operative use of FTA, we restricted its use by spraying only the femoral side. If both the acetabular and femoral sides were sprayed with FTA, an even greater decrease in postoperative bleeding may have resulted. The surgeon's experience is another critical factor in the successful use of FTA.22

The percentage of patients having a blood loss of >1200 ml was significantly lower in the auto-FTA group than in the controls; no allogeneic transfusion was required for patients in either group. Orthopaedic surgery involves dissection of the soft tissue and bone such that bleeding cannot be controlled by conventional surgical techniques alone. In addition, the use of prophylactic anticoagulants to prevent deep vein thrombosis and pulmonary embolism may hinder control of postoperative blood loss. Thus, the use of a haemostatic agent such as FTA is especially beneficial.

Predonation of blood for autologous transfusion requires a special programme and schedule prior to surgery. Some patients cannot predonate a large volume of blood and require treatment with erythropoietin, which is a very expensive agent. In the present study, all patients were able to donate 400 ml of blood 3 weeks prior to surgery without the need for erythropoietin. The decrease in haemoglobin concentration as a result of predonation did not result in any adverse effects. Predonation for autologous blood transfusion is therefore a safe and cost-effective technique, despite being time-consuming.

CONCLUSION

Perioperative blood loss and decrease in haemoglobin level after THA involving adjunctive haemostasis with auto-FTA is significantly decreased, and such treatment is safe and effective.

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