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Controlling femoral fracture surgery bleeding by tranexamic acid

Effect of intraoperative infusion of Tranexamic acid on blood loss volume during Femoral Fracture Surgery: A double-blinded clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017050126328N3
Enrollment
60
Registered
2017-06-27
Start date
2017-05-05
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral fracture intraoperative bleeding. Fracture of femur

Interventions

Intervention 1: Intervention group: 15 minutes prior to incision, 10 mg/kg tranexamic acid will be administered and will be infused during surgery with dosage of 1 mg/kg/hr till end of the surgery. I
Treatment - Drugs
Placebo
Intervention group: 15 minutes prior to incision, 10 mg/kg tranexamic acid will be administered and will be infused during surgery with dosage of 1 mg/kg/hr till end of the surgery.
Control group: 15 minutes prior to incision, 10 mg/kg normal saline (placebo) will be administered and will be infused during surgery with dosage of 1 mg/kg/hr till end of the surgery.

Sponsors

Vice Chancellor for research of Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients candidate for femoral fracture surgery using conture; Class I or II according to ASA classification; aged more than 18 years old. Exclusion criteria: hypersensitivity to tranexamic acid; anemia (hemoglobin lower than 8 gram per 100 milliliter); avoidance from blood transfusion; history of anticoagulant consumption; history of coagulopathies; history of thromboembolism; history of cerebrovascular accidents; history of ischemic heart diseases; pregnancy; major cardiac or pulmonary diseases; hepatic or renal failure; history of epilepsy; history of re-surgery.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Blood loss volume in drain reservoir. Timepoint: during operation and till darin discharge. Method of measurement: maximum allowable blood loss formula.

Secondary

MeasureTime frame
Volume of blood transfusion. Timepoint: during operation and during admission. Method of measurement: C.C.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Masoud Parish

Tabriz University of Medical Sciences

parishm@tbzmed.ac.ir+98 41 3385 5842

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026