Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797156
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2021-03-10
Brief Title:
Combined IV and Topical TXA in Major Spine Surgery
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
The Effect of Combined Intravenous and Topical TXA in Major Multilevel Spine Surgery A Prospective Randomized Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
This is a randomized study The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West Study participation will last from the time of pre-operative evaluation to the time of discharge from hospital Specifically the study team will compare tranexamic acid given only intravenously vs given both topically and intravenously vs given only intravenously but at a higher dosage The study team hypothesizes that patient who received combined topical and intravenous TXA low dose have similar or decreased overall blood loss postoperatively compared to patient who received high or low dose intravenous TXA alone
Detailed Description:
Prospective triple-blinded randomized control trial The surgeon will provide study information protocol consent general information to patients in the surgeons office Recruitment will be done through a coordination of the operating schedule and the surgeons office Patients presenting for preoperative visits at the surgeons office or the preoperative joint clinic will be approached On the day of the surgery the subject will meet the research team in the holding area The team will finalize participation and ask the subject about the signed consent forms and answer any additional questions All patients will be provided with copies of the IRB protocol and consent if they wish to have it Copy of the consent form will be sent in a secured email to the potential subject The email will be secured by entering in SECURE in the e-mail subject line Once recruited blinding assessments will be done by the study team
Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups 1 High Dose Intravenous TXA hTXA group 2 Low Dose Intravenous TXA lTXA group or 3 Combined Intravenous and Topical TXA group cTXA group Surgical team will perform the required spine procedure Study personnel will make the medication which will be labelled as study drug for surgical and anesthesia team to give during the procedure Patients assigned to hTXA group will receive 50mgkg IV TXA loading dose with a 5mgkghr maintenance dose and normal saline poured over 5 minutes at the wound prior to closure Patients assigned to lTXA group will receive 20mgkg IV TXA loading dose with a 5mgkghr maintenance dose and normal saline poured over 5 minutes at the wound prior to closure Patients assigned to cTXA group will received 20mgkg V TXA loading dose with a 5mgkghr maintenance dose and 2g topical TXA poured over 5 minutes at the would prior to closure Otherwise the patient surgeon and anesthesiologist in the case will be blinded
Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups 1 High Dose Intravenous TXA hTXA group 2 Low Dose Intravenous TXA lTXA group or 3 Combined Intravenous and Topical TXA group cTXA group Surgical team will perform the required spine procedure Study personnel will make the medication which will be labelled as study drug for surgical and anesthesia team to give during the procedure Patients assigned to hTXA group will receive 50mgkg IV TXA loading dose with a 5mgkghr maintenance dose and normal saline poured over 5 minutes at the wound prior to closure Patients assigned to lTXA group will receive 20mgkg IV TXA loading dose with a 5mgkghr maintenance dose and normal saline poured over 5 minutes at the wound prior to closure Patients assigned to cTXA group will received 20mgkg V TXA loading dose with a 5mgkghr maintenance dose and 2g topical TXA poured over 5 minutes at the would prior to closure Otherwise the patient surgeon and anesthesiologist in the case will be blinded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None