A Phase 2 interventional study of Tranexamic Acid 15mg/kg , iv, Single Dose and Normal Saline, 100mg, iv, Singe dose in Blood Loss, Surgical, Hip Fractures and Complication, Postoperative, sponsored by National and Kapodistrian University of Athens. Status unknown at 1 site in Greece. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2017-08-16.
Sponsored by National and Kapodistrian University of Athens · Phase 2, 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 6th largest by planned enrollment, is one of 3 that started in 2013, is one of 2 in phase 2, and was the 11th 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: 75 Years and older · all sexes · no healthy volunteers.
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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. 3 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 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.
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1 of 46 have an industry lead sponsor. The 10 most frequent:
National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.
National and Kapodistrian University of Athens has 1 study 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 |
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Among the 46 studies testing Tranexamic Acid in Blood Loss, Surgical, from their registry updates:
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The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
intravenous tranexamic acid, 15mg/kg, preoperatively, single dose
Drug: Tranexamic Acid 15mg/kg , iv, Single Dose
Intravenous normal saline, 100mg, preoperatively, single dose
Drug: Normal Saline, 100mg, iv, Singe dose
Drug page: Tranexamic Acid
Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose
Normal Saline, 100mg, administered intravenously, preoperatively in single dose
number of transfusions of allogeneic RBC from surgery up to day 4
Time frame: 5 days
total blood loss from surgery to day
Time frame: 5 days
incidence of vascular events
Time frame: 3 months
Incidence of deaths
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jan 2013, a primary completion of Dec 2017 and a completion of Feb 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
National and Kapodistrian University of Athens →