Blood Loss, Surgical, Postoperative Hemorrhage
Conditions
Keywords
Bloodloss, Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
Brief summary
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation
Interventions
Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
DRUGPlacebo
Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces.
Exclusion criteria
* Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, or if the subject received aprotinin, the subject should be excluded.- Subjects with a known or suspected allergy to aprotinin. * Subjects with sepsis or a known bone infection.- Subjects with known bone malignancy. * Subjects with a creatinine clearance less than 30mL/min as calculated by the Cockcroft-Gault formula. * Subjects with a history of bleeding diathesis or known coagulation factor deficiency. * Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study * Subjects who refuse to receive allogenic blood products for religious or other reasons. * Subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values \<24% or \<8 g/dl, respectively). * Subjects who have participated in an investigational drug study within the past 30 days * Subjects with a history of deep vein thrombosis or pulmonary embolism. * Subjects who are pregnant or breast feeding. * Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening. * Women of childbearing potential who are not using a reliable method of contraception. * Planned use of other antifibrinolytic agents. * Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of patients requiring a blood transfusion (blood or packed red blood cells, autologous or allogenic) | anytime in the intra-operative or postoperative period (up to the earlier of Day 7 or discharge). |
Secondary
| Measure | Time frame |
|---|---|
| The percent of patients who did and did not predonate blood receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge | surgery to discharge |
| The number of units of blood or packed red cells transfused. There will be analyses for the combination of autologous and allogenic transfusion and for allogenic alone | surgery to discharge |
| The number of units of blood or packed red cells transfused per patient requiring transfusion | surgery to discharge |
| Drainage (in milliliters) from the operative site in the first 8 hours postoperatively, and total drainage until removal of drains or until hospital discharge (whichever is earlier) | surgery to discharge |
| Blood loss during surgery, based on qualitative and quantitative estimates | surgery |
| The percent of patients receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge | surgery to discharge |
| Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures | surgery to discharge |
| The percent of patients receiving colloid or other blood products, and the number of units transfused | surgery to discharge |
| Changes in blood markers related to inflammation and blood coagulation | surgery to discharge |
| Changes in FEV1 | surgery to discharge |
| The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion). | pre-op and day 3 post surgery |
Countries
Canada, Germany, Spain
Outcome results
None listed