A Phase 4 interventional study of Tranexamic Acid and saline in Postoperative Hemorrhage, Breast Neoplasms and Seroma, sponsored by St. Olavs Hospital. Completed at 2 sites in Norway. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-12.
Sponsored by St. Olavs Hospital · Phase 4, Interventional, and Prevention
Among 25 studies testing Tranexamic Acid in Postoperative Hemorrhage — 5 open to participants now, 5 under way, 1 of them phase 3. Tranexamic Acid · Postoperative Hemorrhage.
Among the 25 studies testing Tranexamic Acid in Postoperative Hemorrhage, this one is the 6th largest by enrollment, is the only one that started in 2016, is one of 10 in phase 4, and was the 8th registered.
135 studies on the registry are indexed under Postoperative Hemorrhage; 31 are open to participants now.
This study's enrollment of 202 is above the median of 100 across 102 interventional studies indexed under Postoperative Hemorrhage.
Browse Postoperative Hemorrhage studies →5 of the 25 studies testing Tranexamic Acid in Postoperative Hemorrhage are open now, in 4 countries. Each count lists the studies.
Tranexamic Acid: first FDA approval 1986 (CYKLOKAPRON). What it is approved for, and how studies give it, is on its page →
Of the 17 Postoperative Hemorrhage studies recruiting now, 11 (65%) set no upper age limit and 4 (24%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →25 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2016.
Median enrollment 116 across the 25 interventional studies. Of the 16 that completed or were terminated, 2 (13%) have results posted.
2 of 25 have an industry lead sponsor. The 10 most frequent:
St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
St. Olavs Hospital has 4 studies filed under Postoperative Hemorrhage — fewer than ten, so there is no comparison to draw.
1 of the studies testing Tranexamic Acid in Postoperative Hemorrhage that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06208267St. Mary's Research Center, CanadaTranexamic Acid Use on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty | 2027-04 |
Among the 25 studies testing Tranexamic Acid in Postoperative Hemorrhage, from their registry updates:
Nothing recorded among them since 2026-09-25.
After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer.
After surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.
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:
tranexamic acid to be smeared on surgical wounds before closure
Drug: Tranexamic Acid
saline to be smeared on surgical wounds before closure
Drug: saline
moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
moisten the surgical wound surface with 20 ml placebo (0.9% saline)
bleeding as defined by drain production per hour the first 24 hours
Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml
Time frame: 24 hours postoperatively
Daily drain production up to drain removal - cumulative volume
Time frame: 3 weeks
number of patients having surgical bleeding in need of re-operation
Time frame: 3 weeks
number of postoperative aspirations of clinical seroma
Time frame: up to 3 months
chronic seroma (lasting more than three months)
volume of seroma aspirated
Time frame: 3 months
Plan to share: No
Ran from Jan 2016 to primary completion in Oct 2018, 33 months.
Of 13 phase 4 interventional studies under Postoperative Hemorrhage, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 23. This study's 33 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid