Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290596
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-27
Brief Title:
Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy A Randomized Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
To find the best option to reduce blood loss related to abdominal hysterectomy AH the present randomized double-blinded study sought to compare the effects of locally administered vasopressin VP and tranexamic acid TXA on blood loss in women submitted to AH for benign lesions
Detailed Description:
To find the best option to reduce blood loss related to abdominal hysterectomy AH the present randomized double-blinded study sought to compare the effects of locally administered vasopressin VP and tranexamic acid TXA on blood loss in women submitted to AH for benign lesions
Interventions Study interventions Patients in all groups will receive identically looking pharmaceutical preparations which differ according to the study group
1 Vasopressin group Just before beginning of AH patients in this group will be injected with a 10-ml syringe containing 10 units of VP 5 mL bilaterally 1 cm medial to the uterine vessels in the most distal area of the lower uterine segment not to compromise the bladder If this site is not accessible patients will be alternatively injected in the midline at the fundus Okin et al 2001 In addition and just before closure of peritoneum 100 ml of normal saline NS will be applied topically over the raw surface
2 Tranexamic acid group Just before AH patients in this group will be injected with a 10-ml syringe containing 10 ml of NS 5 mL bilaterally as described above Just before closure of peritoneum 15 g of TXA mixed in 100 ml of NS will be applied topically over the raw surface Mitra et al 2022
3 Control group Just before AH patients in this group will be injected with a 10-ml syringe containing 10 ml of NS 5 mL bilaterally as described above In addition and just before closure of peritoneum 100 ml of normal saline NS will be applied topically over the raw surface
Interventions Study interventions Patients in all groups will receive identically looking pharmaceutical preparations which differ according to the study group
1 Vasopressin group Just before beginning of AH patients in this group will be injected with a 10-ml syringe containing 10 units of VP 5 mL bilaterally 1 cm medial to the uterine vessels in the most distal area of the lower uterine segment not to compromise the bladder If this site is not accessible patients will be alternatively injected in the midline at the fundus Okin et al 2001 In addition and just before closure of peritoneum 100 ml of normal saline NS will be applied topically over the raw surface
2 Tranexamic acid group Just before AH patients in this group will be injected with a 10-ml syringe containing 10 ml of NS 5 mL bilaterally as described above Just before closure of peritoneum 15 g of TXA mixed in 100 ml of NS will be applied topically over the raw surface Mitra et al 2022
3 Control group Just before AH patients in this group will be injected with a 10-ml syringe containing 10 ml of NS 5 mL bilaterally as described above In addition and just before closure of peritoneum 100 ml of normal saline NS will be applied topically over the raw surface
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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