Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320619
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2006-04-28
Brief Title:
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Aminocaproic Acid and Bleeding in Spinal Surgery
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions Research has shown that epsilon-aminocaproic acid EACA may reduce the amount of blood lost during surgery which would decrease the number of blood transfusions required This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery
Detailed Description:
Spine surgery is often required to correct a number of diseases including spondylosis pseudoarthrosis scoliosis or other spinal deformities Spine surgery is often associated with significant blood loss and individuals may require multiple blood transfusions during and following surgery Blood transfusions are expensive and carry an increased risk of health complications including fever allergic reactions or infections Preliminary research has shown that EACA may be beneficial for individuals undergoing spine surgery In addition EACA appears to be safer and less expensive than other medications typically used to treat serious bleeding The purpose of this study is to evaluate the safety and effectiveness of EACA at reducing the number of blood transfusions required during and following spine surgery in adults
This study will enroll individuals who are undergoing spine surgery at Johns Hopkins Hospital Prior to surgery participants demographic data and medical history will be collected Participants will then be randomly assigned to receive either EACA or placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit ICU While in the hospital participants will have blood drawn frequently for laboratory testing They will receive blood transfusions as needed and will be closely monitored for blood loss and any medical surgical or transfusion complications Outcome measurements related to the amount of transfused blood required and postoperative complications will be collected on the 8th day following surgery Study participation will end on the day of hospital discharge or the day of a necessary second surgery
This study will enroll individuals who are undergoing spine surgery at Johns Hopkins Hospital Prior to surgery participants demographic data and medical history will be collected Participants will then be randomly assigned to receive either EACA or placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit ICU While in the hospital participants will have blood drawn frequently for laboratory testing They will receive blood transfusions as needed and will be closely monitored for blood loss and any medical surgical or transfusion complications Outcome measurements related to the amount of transfused blood required and postoperative complications will be collected on the 8th day following surgery Study participation will end on the day of hospital discharge or the day of a necessary second surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23HL070058-03 | NIH | None | httpsreporternihgovquickSearchK23HL070058-03 |