Vasopressin Versus Tranexamic Acid for Control of Blood L... | NCT06290596

Studies
Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy

NCT06290596

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Mar 6, 2024Actual

Enrollment

387Estimated

Phase

Phase 4

Conditions

Uterine Surgery

Interventions

Vasopressin
Tranexamic acid
Saline

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Oct 1, 2024Estimated

Completion Date

Oct 1, 2024Estimated

First Submitted Date

Feb 27, 2024

First Submission Date that Met QC Criteria

Feb 27, 2024

First Posted Date

Mar 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 6, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Warda Demerdash Khalifa Ali, Principal investigator, Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Interventions Study interventions Patients in all groups will receive identically looking pharmaceutical preparations which differ according to the study group

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.
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, 1.5 g of TXA mixed in 100 ml of NS will be applied topically over the raw surface (Mitra et al., 2022).
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

387Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vasopressin group	Experimental	patients in this group will be injected with a 10-ml syringe containing 10 units of vasopressin (5 mL bilaterally)	Drug: Vasopressin
Tranexamic acid group	Experimental	patients in this group will be injected with a 10-ml syringe containing 10 ml of tranexamic acid (5 mL bilaterally).	Drug: Tranexamic acid
Control group	Placebo Comparator	patients in this group will be injected with a 10-ml syringe containing 10 ml of normal saline (5 mL bilaterally).	Other: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vasopressin	Drug	Hemostatic drug.	Vasopressin group
Tranexamic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood loss	Amount of blood loss in mL	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients will be included in the present study if they are indicated for abdominal hysterectomy for benign lesions.

Exclusion Criteria:

history of coagulation or bleeding disorders or
if they were under antithrombotic treatment.
associated malignancy, renal impairment or allergy to TA.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014667	Vasopressins
D014148	Tranexamic Acid
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

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