Trial Outcomes & Findings for Tranexamic Acid for The Treatment of Gastrointestinal Bleeding (NCT NCT03540368)
NCT ID: NCT03540368
Last Updated: 2026-03-27
Results Overview
The number of participants experiencing re-bleeding in each arm was measured within 28 days after randomisation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
28 days after randomisation
Results posted on
2026-03-27
Participant Flow
Between July 1, 2018 and December 31, 2019, 48 patients were enrolled of whom 42 of them were eligible. The trial was done at Cipto Mangunkusumo National Hospital and Budhi Asih Regional Hospital in DKI Jakarta, Indonesia.
Excluded because clinically had CKD
Participant milestones
| Measure |
Tranexamic Acid Injection
Group with tranexamic acid injection
Tranexamic acid injection: Administering tranexamic acid loading dose 1 gram in 100 cc sodium chloride 0,9%, followed by maintenance dose 3 grams in infusion for 24 hours.
|
Placebo
Group with Placebo
Placebo: Administering placebo or sodium chloride 0,9% intravenously
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
23
|
|
Overall Study
COMPLETED
|
19
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tranexamix Acid Group
n=19 Participants
Patients received intravenous TXA (bolus 1 gram in 100 mL normal saline for 10 minutes followed by 3 grams infusion in 500 mL of normal saline for 24 hours) for a total of 24 hours.
|
Placebo
n=23 Participants
Patients received the same volume of placebo infusions for a total of 24 hours.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 13.87 • n=19 Participants
|
53 years
STANDARD_DEVIATION 17.02 • n=23 Participants
|
54.2 years
STANDARD_DEVIATION 15.55 • n=42 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=19 Participants
|
8 Participants
n=23 Participants
|
21 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=19 Participants
|
15 Participants
n=23 Participants
|
21 Participants
n=42 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Indonesia
|
19 participants
n=19 Participants
|
23 participants
n=23 Participants
|
42 participants
n=42 Participants
|
|
Bleeding onset <24 h
|
10 Participants
n=19 Participants
|
12 Participants
n=23 Participants
|
22 Participants
n=42 Participants
|
|
Antiplatelet/anticoagulant
|
3 Participants
n=19 Participants
|
1 Participants
n=23 Participants
|
4 Participants
n=42 Participants
|
|
Comorbidity
|
11 Participants
n=19 Participants
|
17 Participants
n=23 Participants
|
28 Participants
n=42 Participants
|
|
Compensated cirrhosis
|
3 Participants
n=19 Participants
|
4 Participants
n=23 Participants
|
7 Participants
n=42 Participants
|
|
Decompensated cirrhosis
|
1 Participants
n=19 Participants
|
8 Participants
n=23 Participants
|
9 Participants
n=42 Participants
|
|
Glasgow-Blatchford score
|
9.7 Scores on a scale (0-23)
STANDARD_DEVIATION 3.26 • n=19 Participants • The Glasgow-Blatchford Score (GBS) is a clinical risk scoring system used to assess the severity of upper gastrointestinal bleeding and predict the need for medical intervention. The total score ranges from 0 to 23, with higher scores indicating a greater risk of severe bleeding and a higher likelihood of requiring intervention.
|
9.9 Scores on a scale (0-23)
STANDARD_DEVIATION 2.95 • n=23 Participants • The Glasgow-Blatchford Score (GBS) is a clinical risk scoring system used to assess the severity of upper gastrointestinal bleeding and predict the need for medical intervention. The total score ranges from 0 to 23, with higher scores indicating a greater risk of severe bleeding and a higher likelihood of requiring intervention.
|
9.8 Scores on a scale (0-23)
STANDARD_DEVIATION 3.06 • n=42 Participants • The Glasgow-Blatchford Score (GBS) is a clinical risk scoring system used to assess the severity of upper gastrointestinal bleeding and predict the need for medical intervention. The total score ranges from 0 to 23, with higher scores indicating a greater risk of severe bleeding and a higher likelihood of requiring intervention.
|
|
Haemoglobin
|
7.79 g/dL
STANDARD_DEVIATION 2.903 • n=19 Participants
|
8.52 g/dL
STANDARD_DEVIATION 3.511 • n=23 Participants
|
8.19 g/dL
STANDARD_DEVIATION 3.233 • n=42 Participants
|
|
Upper GI bleeding
|
19 Participants
n=19 Participants
|
23 Participants
n=23 Participants
|
42 Participants
n=42 Participants
|
|
Variceal bleeding
|
5 Participants
n=19 Participants
|
12 Participants
n=23 Participants
|
17 Participants
n=42 Participants
|
|
Inhospital endoscopy
|
9 Participants
n=19 Participants
|
12 Participants
n=23 Participants
|
21 Participants
n=42 Participants
|
|
PRC transfusion (mL)
|
751.1 milliliter
STANDARD_DEVIATION 649.63 • n=19 Participants
|
906.5 milliliter
STANDARD_DEVIATION 956.24 • n=23 Participants
|
836.2 milliliter
STANDARD_DEVIATION 825.87 • n=42 Participants
|
PRIMARY outcome
Timeframe: 28 days after randomisationThe number of participants experiencing re-bleeding in each arm was measured within 28 days after randomisation
Outcome measures
| Measure |
Tranexamix Acid Group
n=19 Participants
Patients received intravenous TXA (bolus 1 gram in 100 mL normal saline for 10 minutes followed by 3 grams infusion in 500 mL of normal saline for 24 hours) for a total of 24 hours.
|
Placebo
n=23 Participants
Patients received the same volume of placebo infusions for a total of 24 hours.
|
|---|---|---|
|
Re-bleeding
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 30 days after randomisationTotal number patients who die
Outcome measures
| Measure |
Tranexamix Acid Group
n=19 Participants
Patients received intravenous TXA (bolus 1 gram in 100 mL normal saline for 10 minutes followed by 3 grams infusion in 500 mL of normal saline for 24 hours) for a total of 24 hours.
|
Placebo
n=23 Participants
Patients received the same volume of placebo infusions for a total of 24 hours.
|
|---|---|---|
|
All Cause Mortality
|
4 Participants
|
5 Participants
|
Adverse Events
Tranexamix Acid Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 4 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Tranexamix Acid Group
n=19 participants at risk
Patients received intravenous TXA (bolus 1 gram in 100 mL normal saline for 10 minutes followed by 3 grams infusion in 500 mL of normal saline for 24 hours) for a total of 24 hours.
|
Placebo
n=23 participants at risk
Patients received the same volume of placebo infusions for a total of 24 hours.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thromboembolism
|
5.3%
1/19 • Number of events 1 • Adverse event collected during injection until 30 days after injection
|
4.3%
1/23 • Number of events 1 • Adverse event collected during injection until 30 days after injection
|
Other adverse events
Adverse event data not reported
Additional Information
Ari Fahrial Syam
Division of Gastroenterology, Department of Internal Medicine Faculty of Medicine Universitas Indonesia -- Dr. Cipto Mangunkusumo National Center General Hospital
Phone: +62213153957
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place