Phase 4
N=94
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
Biliary Tract Surgical Procedures · Pancreaticoduodenectomy · Esophagectomy · Colectomy · Gastrectomy
Bottom Line
View on ClinicalTrials.gov: NCT00827931 ↗Enrolled (actual)
94
Serious AEs
17.0%
Results posted
Apr 2012
Primary outcome: Primary: Post-operative Blood Loss — 394.3; 494.3 milliliter (mL) — p=0.460
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic acid + Standard of Care (Drug); Standard of Care (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Blood Loss |
394.3; 494.3 | 0.460 |
| SECONDARY Intra-operative Blood Loss |
599.2; 682.8 | 0.579 |
| SECONDARY Total Blood Loss |
993.6; 1177.1 | 0.452 |
| SECONDARY Total Blood Loss as Assessed by the Gross' Formula |
17.8; 435.5 | 0.010 sig |
| SECONDARY Percentage of Participants Receiving Transfusions |
21.7; 14.3 | 0.701 |
| SECONDARY Hemoglobin Levels |
11.6; 12.1; 11.3; 11.6; 10.4; 11.0 | — |
| SECONDARY Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery |
0; 0 | — |
Summary
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.
Eligibility Criteria
Inclusion Criteria
- Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)
Exclusion Criteria
- Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.
- Patients with known coagulopathy.
- Patients with anemia (hemoglobin levels less than 8 mg/dl)
- Patients with documented DVT or PE at screening or in past three months.
- Patients with any associated major illness (e.g., severe cardiac or respiratory disease).
- Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
Data sourced from ClinicalTrials.gov (NCT00827931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.