NCT02903017

Brief Summary

Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. The investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

September 12, 2016

Last Update Submit

March 5, 2018

Conditions

Gastrointestinal HemorrhageTranexamic AcidEmergency DepartmentAntifibrinolytic Agents

Outcome Measures

Primary Outcomes (5)

  • Mortality

    In- or out of hospital mortality

    One month

  • Re-bleeding

    Recurrent upper gastrointestinal hemorrhage

    One month

  • Endoscopic intervention need

    One month

  • Surgical intervention need

    One month

  • ED revisit

    One month

Secondary Outcomes (3)

  • Length of stay in the hospital

    One month

  • Administered blood products in the ED

    One month

  • Adverse reactions

    One month

Study Arms (2)

Tranexamic acid 5%

ACTIVE COMPARATOR

Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL)

Drug: Tranexamic acid 5%

Placebo

PLACEBO COMPARATOR

0.9% normal saline solution (total 100 mL)

Drug: Placebo

Interventions

Tranexamic acid 5%DRUG

Via nasogastric tube, 100 mL

Tranexamic acid 5%
PlaceboDRUG

Via nasogastric tube, 100 mL

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with upper gastrointestinal hemorrhage to the ED
  • Patients older than 18 years
  • Patients who agree to participate the study by reading and signing the informed consent form

You may not qualify if:

  • Patients younger than 18 years
  • Patients who do not agree to participate the study
  • Documented or declared allergy to tranexamic acid
  • Upper gastrointestinal hemorrhage secondary to trauma
  • Upper gastrointestinal hemorrhage secondary to esophageal varices
  • Patients who cannot undergo to endoscopy for any reason
  • History for thromboembolic disease
  • Patients with renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University, Faculty of Medicine

Kocaeli, 41050, Turkey (Türkiye)

Location

Related Publications (3)

  • Hawkey GM, Cole AT, McIntyre AS, Long RG, Hawkey CJ. Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points. Gut. 2001 Sep;49(3):372-9. doi: 10.1136/gut.49.3.372.

    PMID: 11511559BACKGROUND

  • Bergqvist D, Dahlgren S, Hessman Y. Local inhibition of the fibrinolytic system in patients with massive upper gastrointestinal hemorrhage. Ups J Med Sci. 1980;85(2):173-8. doi: 10.3109/03009738009179185.

    PMID: 7018048BACKGROUND

  • Cormack F, Chakrabarti RR, Jouhar AJ, Fearnley GR. Tranexamic acid in upper gastrointestinal haemorrhage. Lancet. 1973 Jun 2;1(7814):1207-8. doi: 10.1016/s0140-6736(73)90525-4. No abstract available.

    PMID: 4122561BACKGROUND

MeSH Terms

Conditions

Gastrointestinal HemorrhageEmergencies

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Nurettin Özgür Doğan, M.D., Assoc. Prof.

    Kocaeli University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Associate Professor

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 16, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

TU(1)