Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580509
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage TEAPOT A Pilot and Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEAPOT
Brief Summary:
After a child has their tonsils removed sometimes they might bleed which can be a problem There is a special mist medicine called nebulized tranexamic acid TXA that might help stop the bleeding without having to touch the sore spot If this mist works well it could help kids get better by making sure they dont have to go back for more surgery or need blood from someone else Not having another surgery is good because it means kids wont have to sleep under medicine again which can sometimes be risky for their brains and breathing and they wont feel as scared or hurt
Detailed Description:
The study intervention involves administering nebulized tranexamic acid TXA to pediatric patients with traumatic hemorrhage PTH The intervention consists of three consecutive doses of nebulized TXA
The dosage of nebulized TXA is adjusted based on the childs weight For children weighing more than 25 kg each dose is 500 mg For children weighing less than 25 kg each dose is 250 mg
Frequency The three doses of nebulized TXA are administered consecutively over the course of approximately an hour Administration Method Nebulized TXA is delivered through a nebulizer device A nebulizer converts the liquid medication into a fine mist or aerosol which is then inhaled by the patient This method allows the medication to be delivered directly to the respiratory tract where it can exert its effect on the bleeding site Delivery Setting The intervention may take place in a clinical setting such as a hospital or outpatient clinic where nebulizer devices and medical supervision are readily available Each patient receives three nebulized independent doses of TXA in succession The delivery of the intervention is carried out by healthcare professionals trained in administering nebulized medications
The dosage of nebulized TXA is adjusted based on the childs weight For children weighing more than 25 kg each dose is 500 mg For children weighing less than 25 kg each dose is 250 mg
Frequency The three doses of nebulized TXA are administered consecutively over the course of approximately an hour Administration Method Nebulized TXA is delivered through a nebulizer device A nebulizer converts the liquid medication into a fine mist or aerosol which is then inhaled by the patient This method allows the medication to be delivered directly to the respiratory tract where it can exert its effect on the bleeding site Delivery Setting The intervention may take place in a clinical setting such as a hospital or outpatient clinic where nebulizer devices and medical supervision are readily available Each patient receives three nebulized independent doses of TXA in succession The delivery of the intervention is carried out by healthcare professionals trained in administering nebulized medications
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