A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial

<p>Abstract</p> <p>Background</p> <p>The development of suture hole bleeding at peripheral arterial bypass anastomoses using PTFE graft prostheses is a common problem in peripheral vascular surgery. Traditionally the problem is managed by compression with surgical swabs and reversal heparin or by using several haemostatic device (e.g. different forms of collagen, oxidized cellulose, gelatine sponge, ethylcyanoacrylate glue or fibrin) with various success. Preclinical data suggest that the haemostatic effect of collagen is stronger than that of oxidized cellulose, but no direct clinical comparison of their hemostatic performance has been published so far.</p> <p>Design</p> <p>This randomized, controlled, prospective trial evaluates the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis. 28 patients undergoing an elective peripheral vascular reconstruction due to peripheral vascular disease will be included. Suture hole bleeding occurring at the arterial bypass anastomosis using a PTFE prostheses will be stopped by the application of Lyostypt and/or Surgicel. The proximal anastomoses will be randomized intraoperatively. The patients will be allocated into 4 different treatment groups. Group1 Lyostypt distal/Surgicel proximal; Group 2: Lyostypt proximal/Surgicel distal; Group 3: Surgicel distal and proximal; Group 4: Lyostypt distal and proximal. Primary endpoint of the study is time to haemostasis. Secondary endpoints are the number of intraoperatively used haemostatic devices, postoperative mortality within 30 days as well as the intraoperative efficacy rating of the two devices evaluated by the surgeon. As a safety secondary parameter, the local and general complication occurring till 30 ± 10 days postoperatively will also be analysed. After hospital discharge the investigator will examine the enrolled patients again at 30 days after surgery.</p> <p>Discussion</p> <p>The COBBANA trial aims to assess, whether the haemostatic effect of Lyostypt is superior to Surgicel in suture hole bleedings of arterial bypass anastomoses.</p> <p>Trial registration</p> <p>NCT00837954</p

Decreased myometrial beta-adrenoceptors in women receiving beta 2-adrenergic tocolytic therapy: correlation with lymphocyte beta-adrenoceptors

We have determined simultaneously the density of beta-adrenoceptors in human myometria (by (-)-[125I]iodopindolol binding) derived from 36 women undergoing cesarean section and in the corresponding circulating lymphocytes (by (-)-[125I]iodocyanopindolol binding). In myometrial membranes about 80% to 85% of the beta-adrenoceptors were of the beta 2-subtype. The density of myometrial and lymphocyte beta-adrenoceptors in women treated with the beta 2-adrenoceptor agonist hexoprenaline to prevent preterm labor was about 65% to 70% lower than that in nontreated women. Concomitantly, in hexoprenaline-treated women the 10 mumol/L isoproterenol-evoked increase in lymphocyte cyclic adenosine monophosphate content (as index for lymphocyte beta-adrenoceptor responsiveness) was diminished to a similar extent. Combining all data resulted in a significant positive correlation between myometrial and lymphocyte beta-adrenoceptor densities (r = 0.7303; n = 36; p less than 0.001). It is possible that determination of beta-adrenoceptor function in circulating lymphocytes may be a useful model to monitor myometrial beta-adrenoceptor changes during tocolytic therap