A study presented at EUROSPINE 2015 (2–4 September, Copenhagen, Denmark) exhibited success using Gelatine matrix with human thrombin to reduce intraoperative blood loss alongside traditional haemostasis techniques.
Ilkka Helenius, Turku University Central Hospital, Finland, and colleagues showed that during adolescent idiopathic scoliosis surgery, Gelatine matrix with human thrombin can reduce the risks of major intraoperative bleeding. Such bleeding is a significant worry for surgeons carrying out this procedure, even more so when more than nine levels are being fused or when a posterior, rather than anterior, approach is used. Major bleeding during a procedure can occur in the cancellous bone, epidural space and vascular paraspinal muscles.
Gelatine matrix with human thrombin—a topically applied haemostat—has been “widely used in spinal deformity surgery,” Helenius told the audience. However, there has only been one randomised trial examining its use in adult degenerative lumbar spine surgery (in 2001), showing that although it allowed a faster control of bleeding, it did not have an effect on overall blood loss. There have been complications reported from its use in spinal deformity surgery, including epidural spinal cord compression and anaphylaxis, although these are “rare”.
This study was a randomised, multicentre trial conducted in accordance with CONSORT guidelines. Helenius and colleagues enrolled 60 patients who were all diagnosed with juvenile or adolescent idiopathic scoliosis between 45 and 90 degrees. All were aged between 10 and 21 years and underwent posterior fusion with bilateral pedicle screws (mean number of levels fused was 11 for both groups, p=0.40). Half were randomised to receive the Gelatine matrix with human thrombin intervention (between 2 and 4 units, 500IU/ml, 5ml per unit) and half to the control group. Normal surgical haemostatic methods were allowed in both groups, and both groups received intraoperative tranexamic acid.
Radiographic outcomes were similar for both groups. Major curve correction was 78% for the control group and 75% for the intervention group (p=0.96) and only one complication was reported in either group (one patient in the control group).
Every operative hour increased blood loss by 357ml. Intervention decreased intraoperative blood loss (adjusted for operating room time and the number of pedicles instrumented) by 171ml (31%) more than in the control group (95% confidence interval [CI], -320 to -22ml, p=0.025).
For total blood loss (intraoperative blood loss + drain output) every operative hour resulted in another 431ml lost. Intervention decreased adjusted total blood loss by 177ml (17%) when compared with the control group (95% CI, -333 to -21ml, p=0.027).
The trend remained true for postoperative haemoglobin levels. For every pedicle instrumented, haemoglobin levels fell by 2.6g/l. Intervention reduced haemoglobin decreases by 6 g/L (95% CI, -10.7 to -1.3g/l, p=0.013).
Helenius thus concluded that “The use of Gelatine matrix with human thrombin decreases intraoperative and postoperative blood loss when added to traditional surgical haemostasis techniques in children and adolescents undergoing posterior spinal fusion for adolescent idiopathic scoliosis using all pedicle screw constructs. Postoperative decrease in haemoglobin is also slightly less in the intervention group than in the control group. We were unable to observe any adverse events related to its use.”