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TachoSil surgical patch versus conventional haemostatic fleece material for control of bleeding in cardiovascular surgery: a randomised controlled trial

^a Istituto Scientifico H San Raffaele, Via Olgettina, 60, Milan 20132, Italy
^b Rigshospitalet Heart and Lung Surgical Clinic, Copenhagen, Denmark
^c German Heart Center, Cardiovascular Surgery, Munich, Germany
^d Heart Institute Pitie Salpetriere, Paris, France
^e Clinica Universitaria de Navarra, Department of Cardiovascular Surgery, Navarra, Spain
^f University Hospital Dupuytren, Limoges, France
^g Nycomed, Roskilde, Denmark
^h Heart Center Leipzig, Department of Cardiac Surgery, Leipzig, Germany

Received 5 February 2009; received in revised form 29 April 2009; accepted 30 April 2009.

^_* Corresponding author. Tel.: +39 02 2643 7111; fax: +39 02 2643 7125. (Email: francesco.maisano{at}hsr.it).

Objective: Prolonged bleeding during cardiovascular surgery presents a risk for the patient and increases the time and cost of surgery. TachoSil^® is a ready-to-use haemostatic agent that consists of an equine collagen patch coated with human fibrinogen and thrombin. This trial evaluated the efficacy and safety (30 days post-surgery) of TachoSil surgical patch compared with standard haemostatic fleece for the control of bleeding in patients undergoing cardiovascular surgery. Methods: Patients scheduled for elective surgery on the heart, ascending aorta or aortic arch requiring cardiopulmonary bypass were eligible for this open-label multicentre trial. After primary haemostatic measures, patients were randomised to TachoSil or conventional haemostatic fleece if an area of persisting haemorrhage was identified (target area). After the application of trial treatment, haemostasis was evaluated at 3 min (primary endpoint). If haemostasis was not achieved, trial treatment was re-applied and haemostasis assessed at 6 min (secondary endpoint). Results: A total of 120 patients were randomised and 119 received trial treatment (TachoSil, n = 59; standard treatment, n = 60). Twenty-six percent of patients were female and the mean age was 67 years (range: 23–86 years). Baseline characteristics were similar in both the groups. Bleeding occurred mainly from the aorta (56%), right ventricle (16%) or right atrium (13%), more often from a vessel (68%) than tissue (32%), and was assessed to be arterial in 74% of cases. TachoSil was significantly superior to standard haemostatic fleece in controlling bleeding after insufficient primary haemostasis, with 75% (95% confidence interval (CI): 0.64–0.86) of the TachoSil group achieving haemostasis at 3 min compared with only 33% (95% CI: 0.21–0.45) of the standard treatment group (p < 0.0001). This difference persisted at 6 min, with 95% of patients achieving haemostasis in the TachoSil group compared with 72% in the standard treatment group (p = 0.0006). Three (5%) TachoSil patients compared with 17 (28%) standard treatment patients failed to achieve haemostasis at 6 min and received rescue treatment. TachoSil was well tolerated with adverse events generally similar in the two treatment groups. Conclusions: TachoSil was significantly superior to standard haemostatic fleece material in obtaining effective and fast intra-operative haemostasis in cardiovascular surgical procedures. TachoSil was safe and well tolerated.

Key Words: Cardiovascular surgical procedures • Haemostasis • TachoSil