CompletedPhase 3ACTRN12611000865910
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
Sponsor
John Hunter Hospital
Enrollment
100 participants
Start Date
Nov 9, 2011
Study Type
Interventional
Conditions
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.
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Inclusion Criteria3
- Written informed consent
- Per rectum bleeding
- Able to swallow study medications
Exclusion Criteria10
- 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.
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Interventions
Tranexamic acid 1000mg taken orally every 6 hours for 4 days.
Tranexamic acid 1000mg taken orally every 6 hours for 4 days.
Locations(1)
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ACTRN12611000865910