A Phase III Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy of Tranexamic Acid in Reducing the Blood Loss in Patients with Per-rectal Bleeding

A Phase III Randomised, Double-blind, Placebo-controlled Pragmatic Trial to Assess the Efficacy of Tranexamic Acid in Reducing the Blood Loss in Patients with Per-rectal Bleeding

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000865910

Acronym

TRAPR Study

Enrollment

100

Registered

2011-08-15

Start date

2011-11-09

Completion date

2014-01-07

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A study to assess the effectiveness of oral tranexamic acid to placebo in reducing the amount of blood loss from lower gastrointestinal bleeding, and to reduce the amount of blood needed to be transfused.

Interventions

Tranexamic acid 1000mg taken orally every 6 hours for 4 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Written informed consent Per rectum bleeding Able to swallow study medications

Exclusion criteria

Subjects less than 18 years Patients with dementia or other health conditions that prevent a person from giving written informed consent. History of thromboembolic disease or family history of same. Subjects taking warfarin. Subjects that are within 12 months of insertion of a drug-eluting stent. Subjects that are within 12 weeks of placement of a bare metal stent. Subjects that are pregnant and/or breastfeeding. Subjects with a known gastrointestinal malignancy Subjects with a known cancer in the palliative care phase of their treatment. Subjects with a known allergy to tranexamic acid or its excipients.

Outcome results