A Phase 4 interventional study of Tranexamic Acid in Bleeding and Surgical Blood Loss, sponsored by Population Health Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Population Health Research Institute · Phase 4, Interventional, and Prevention
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Among 46 studies testing Tranexamic Acid in Blood Loss, Surgical — 9 open to participants now, 9 under way, 4 of them phase 3. Tranexamic Acid · Blood Loss, Surgical.
Among the 46 studies testing Tranexamic Acid in Blood Loss, Surgical, this one is the 24th largest by enrollment, is one of 4 that started in 2017, is one of 18 in phase 4, and was the 16th registered.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
Browse Blood Loss, Surgical studies →9 of the 46 studies testing Tranexamic Acid in Blood Loss, Surgical are open now, in 6 countries. Recruiting first, the newest first:
The University of Texas Health Science Center at San Antonio · Sites in United States
Ages 2–17
Wolfson Medical Center · Sites in Israel
Ages 18–51 · Women only · Healthy volunteers
The University of Texas Health Science Center at San Antonio · Sites in United States
Ages 2–17
Assiut University · Sites in Egypt
Ages 18–65 · Healthy volunteers
University of Virginia · Sites in United States
Ages 18+ · Women only
By country, each count listing its studies:
Tranexamic Acid: first FDA approval 1986 (CYKLOKAPRON). What it is approved for, and how studies give it, is on its page →
Of the 27 Blood Loss, Surgical studies recruiting now, 10 (37%) set no upper age limit and 14 (52%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 6 · Phase 3 12 · Phase 4 18
First in 2007; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 97 is above the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Median enrollment 98 across the 46 interventional studies. Of the 27 that completed or were terminated, 8 (30%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 46 have an industry lead sponsor. The 10 most frequent:
Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Population Health Research Institute has 2 studies filed under Blood Loss, Surgical — fewer than ten, so there is no comparison to draw.
3 of the studies testing Tranexamic Acid in Blood Loss, Surgical that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03553186Phase 3Hospital for Special Surgery, New YorkTranexamic Acid in Adult Spinal Deformity Surgery | 2027-03 |
| NCT07565753The University of Texas Health Science Center at San AntonioTEAPOT Study Multisite | 2027-09-30 |
| NCT06580509The University of Texas Health Science Center at San AntonioTranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study | 2027-09-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 46 studies testing Tranexamic Acid in Blood Loss, Surgical, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will assess the feasibility to perform a large randomized international trial exploring this objective.
Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TA is used directly on the tissues (topically) for other type of surgeries (joints), TA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's enrollment of 97 is above the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Compared within Blood Loss, Surgical, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hemorrhage. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 syringe of 50ml of topical Tranexamic Acid (5g) or placebo. The topical will be poured into the pericardial mediastinal cavities in 2 equal doses, 25ml when the pt comes off-pump and the other 25ml before sternotomy is closed.
Drug: Tranexamic Acid
2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo.
Drug: Tranexamic Acid
Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.
Also known as: Cyklokapron
Median Volume of Mediastinal Fluid Collected From Participants
Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure
Time frame: Fluid collected in the first 24 hours after the surgical procedure
Number of Participants With Seizures
Patients experiencing a post-operative seizure
Time frame: Patients will be followed post-operatively until hospital discharge
Number of Participants With Mortality
The occurrence of death due to any cause
Time frame: Patients will be followed post-operatively until hospital discharge
Number of Participants With RBC Transfusion
Patients requiring a red blood cell transfusion
Time frame: Intra-operative and post-operative RBC transfusions
Number of Participants With Re-operation for Bleeding or Tamponade
Occurrence of re-operation for the purpose of bleeding or cardiac tamponade
Time frame: Patients will be followed post-operatively until hospital discharge
Median Number of Hours Participants Spent in ICU
Number of hours participants spent in the intensive care unit (ICU)
Time frame: Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).
Mean Concentration of TxA in Plasma Collected From Participants
Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU
Time frame: on arrival in ICU within 3 hours
Between December 2017 and April 2018 a total of 97 patients were randomized to the topical (n = 49) and intravenous (n = 48) groups.
| Milestone | Topical TxA (Intervention) | Intravenous TxA (Control) |
|---|---|---|
| Started | 49 | 48 |
| Completed | 49 | 48 |
| Not completed | 0 | 0 |
Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure
| mL | Topical TxA (Intervention) | Intravenous TxA (Control) |
|---|---|---|
| Median Volume of Mediastinal Fluid Collected From Participants | 500 (350 to 750) | 540 (420 to 700) |
Patients experiencing a post-operative seizure
| Participants | Topical TxA (Intervention) | Intravenous TxA (Control) |
|---|---|---|
| Number of Participants With Seizures | 0 | 1 |
The occurrence of death due to any cause
| Participants | Topical TxA (Intervention) | Intravenous TxA (Control) |
|---|---|---|
| Number of Participants With Mortality | 1 | 1 |
Patients requiring a red blood cell transfusion
| Participants | Topical TxA (Intervention) | Intravenous TxA (Control) |
|---|---|---|
| Number of Participants With RBC Transfusion | 19 | 23 |
Occurrence of re-operation for the purpose of bleeding or cardiac tamponade
| Participants | Topical TxA (Intervention) | Intravenous TxA (Control) |
|---|---|---|
| Number of Participants With Re-operation for Bleeding or Tamponade | 0 | 1 |
Number of hours participants spent in the intensive care unit (ICU)
| hours | Topical TxA (Intervention) | Intravenous TxA (Control) |
|---|---|---|
| Median Number of Hours Participants Spent in ICU | 23 (19 to 45) | 26 (22 to 53) |
Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU
| microgram per milliliter per kilogram | Topical TxA (Intervention) | Intravenous TxA (Control) |
|---|---|---|
| Mean Concentration of TxA in Plasma Collected From Participants | 0.58 ± 0.41 | 1.10 ± 0.52 |
Collected over 30 days post-operatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topical TxA (Intervention) | 1/49 (2%) | 0/49 (0%) | 0/49 (0%) |
| Intravenous TxA (Control) | 1/48 (2.1%) | 0/48 (0%) | 0/48 (0%) |
| Age, Continuous(years) | Topical TxA (Intervention) | Intravenous TxA (Control) | Total |
|---|---|---|---|
| Mean | 67.3 ± 9.4 | 67.8 ± 9.2 | 67.5 ± 9.2 |
| Sex: Female, Male(Participants) | Topical TxA (Intervention) | Intravenous TxA (Control) | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 44 | 42 | 86 |
| Race/Ethnicity, Customized(Participants) | Topical TxA (Intervention) | Intravenous TxA (Control) | Total |
|---|---|---|---|
| White/Caucasian | 46 | 46 | 92 |
| Hispanic/Latino | 0 | 2 | 2 |
| Southeast Asian/Malaysian | 1 | 0 | 1 |
| Aboriginal/Native Persons | 2 | 0 | 2 |
| Region of Enrollment(participants) | Topical TxA (Intervention) | Intravenous TxA (Control) | Total |
|---|---|---|---|
| Canada | 49 | 48 | 97 |
| Diabetes mellitus(Participants) | Topical TxA (Intervention) | Intravenous TxA (Control) | Total |
|---|---|---|---|
| Count of participants | 17 | 21 | 38 |
| Stroke(Participants) | Topical TxA (Intervention) | Intravenous TxA (Control) | Total |
|---|---|---|---|
| Count of participants | 3 | 3 | 6 |
| Transient ischemic attack(Participants) | Topical TxA (Intervention) | Intravenous TxA (Control) | Total |
|---|---|---|---|
| Count of participants | 2 | 2 | 4 |
| Carotid endarterectomy/stent(Participants) | Topical TxA (Intervention) | Intravenous TxA (Control) | Total |
|---|---|---|---|
| Count of participants | 3 | 1 | 4 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Sep 2018, 8 months.
Results were first posted in Sep 2019, 1 year after primary completion.
Of 24 non-industry phase 4 interventional studies under Blood Loss, Surgical, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's 8 months is below that.
Counting every sponsor, half of 24 studies reached it within 12 months; a quarter within 8 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
Population Health Research Institute →