Effect of Prophylactic Tranexamic Acid on Bleeding Outcom... | NCT04651166

Studies
Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation

NCT04651166

Sponsor

University of Hawaii

Status

Completed

Last Update Posted

Sep 6, 2023Actual

Enrollment

48Actual

Phase

Phase 2

Conditions

Abortion
Dilation and Evacuation
Hemorrhage
Blood Loss

Interventions

Tranexamic acid
Placebo

Countries

United States

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2022Actual

Primary Completion Date

Jul 27, 2023Actual

Completion Date

Jul 27, 2023Actual

First Submitted Date

Nov 25, 2020

First Submission Date that Met QC Criteria

Nov 25, 2020

First Posted Date

Dec 3, 2020Actual

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

Aug 31, 2023

Last Update Posted Date

Sep 6, 2023Actual

Name	Class
Society of Family Planning	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D&E at 16 to 24 weeks gestation.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure	Drug: Placebo
Active Comparator	Active Comparator	1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure	Drug: Tranexamic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic acid	Drug	1g tranexamic acid mixed in 100mL saline or lactated ringer	Active Comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intervention to control blood loss	Rate at which providers perform interventions to control blood loss during D&E procedures	At time of procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Requesting pregnancy termination
Intrauterine pregnancy at 16 to 24 weeks gestation
Participants must be willing and capable of giving informed consent and able to understand and sign written consents in English.

Exclusion Criteria:

History of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marit Pearlman Shapiro	University of Hawaii	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queens Medical Center		Honolulu	Hawaii	96814	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D004108	Dilatation, Pathologic
D006470	Hemorrhage

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid

Ancestor Terms

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided