the effect of systemic and local injection of tranxamic acid on blood loss and need to transfusion in acetabulum surgery (Transverse, T Type and associated fracture)
the effect of systemic and local injection of tranexamic acid on blood loss and need to transfusion in acetabulum surgery (Transverse, T Type and associated fracture)
Design
randomized, blinded, controlled clinical trial with a parallel-group design of 100 patients
Settings and conduct
the patient who admitted to Tabriz Shohada Hospital from 2020 to 2022 Will participate in the study.
Patients included in the study will be infused 1gr of TXA in 100cc N/S before surgical incision. After the surgery is completed 3gr TXA will be applied locally in the surgery field. blood loss during surgery will calculate by the number of blood-stained gases, Suction tank volume, and bleeding in the field of surgery. bleeding volume after surgery will calculate by volume of Hemovac drain in 24 and 48hr after surgery. Hb level will calculate after surgery and before discharge. All patients will receive DVT prophylaxis. All patients will undergo color doppler sonography to evaluate thrombotic complications after 3 weeks of surgery. the study will be double-blinded with the patient and caregiver(surgeon and radiologist). they will not be aware of the treatment of the groups
Participants/Inclusion and exclusion criteria
Patients over 18 years with acetabular fractures except for patients with a history of tranexamic acid allergy, thrombolytic disease, congenital coagulopathy, and preoperative massive transfusion
Intervention groups
This study will investigate the effect of the TXA on control of bleeding and the need for transfusion in case and control groups
Main outcome variables
hemoglobin level؛ transfusion؛ deep vein thrombosis؛ bleeding volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045664N1
Registration date:2019-12-19, 1398/09/28
Registration timing:prospective
Last update:2019-12-19, 1398/09/28
Update count:0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
Aliasghar Tanha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3608 0425
Email address
tanha_med@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of systemic and local injection of tranxamic acid on blood loss and need to transfusion in acetabulum surgery (Transverse, T Type and associated fracture)
Public title
effect of tranxamic acid on blood loss and need to transfusion in pelvic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient over 18 year's old with T Type, Transverse and associated acetabular fracture
Exclusion criteria:
sensitive to tranxamic acid
history of thrombotic disease
coagulopathy disorder
renal and hepatic function disorder
patient with multi fracture who need multiple surgery
history of CVA
history of coronary stent
Patients treated with anticoagulants
massive transfusion before surgery
sensitive to drugs
patients treat with anticoagulats
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, clinical caregivers and patients participating in the study will be blind.
All patients will be aware of the benefits and potential consequences of clinical trial, but They will be unaware about who will receive the intervention.
All patients will be treated by a surgeon and he will be blind about tranexamic acid order. Tranexsamic acid transfusion will be administered just before surgery by an anesthesiologist. Topical injection will be applied to all patients in 30 cc solution at the end of surgery. some of them will receive placebo(normal saline solution). after 3 week of surgery, patients will be evaluated for vascular thrombosis by color Doppler ultrasound by a Radiologist. He will not be aware of the group who give intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Shohada Hospital, Golshahr, Baharestan, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5733395193
Approval date
2019-12-08, 1398/09/17
Ethics committee reference number
IR.TBZMED.REC.1398.946
Health conditions studied
1
Description of health condition studied
Acetabulum fracture
ICD-10 code
S32.4
ICD-10 code description
Fracture of acetabulum
Primary outcomes
1
Description
hemoglobin level
Timepoint
before surgery, 24 and 48he after surgery
Method of measurement
with automatic cell counter in laboratory
2
Description
deep vein thrombosis
Timepoint
3 weeks after surgery
Method of measurement
with color doppler sonography by the radiologist
3
Description
bleeding volume
Timepoint
during and after surgery
Method of measurement
The volume of the suction tank, the number of gases-stained with blood, and bleeding of the surgery field. volume of the hemovak drain after surgery
4
Description
Blood transfuion
Timepoint
Before surgery; after 24 and 48hr of surgery
Method of measurement
According to Hb level
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before surgical excision of this group, they will be infused with 1 gram of tranexamic acid dissolved in 100 ml of normal saline. 3 grams of tranexamic acid dissolved in 30 cc normal saline is applied topically at the site of surgery after the end of surgery.
Category
Treatment - Drugs
2
Description
Control group: The control group received no injection of tranexamic acid and The placebo will use in the field of surgery