Randomized study evaluating the effect tranexamic acid on hemorrhage in cleft palate reconstraction surgery.
Double-blind randomized study comparing intraoperative bleeding in palatoplasty between patients who received tranexamic acid at a dose of 10 mg/kg bolus followed by continuous infusion of 1 mg/kg/h until the end of the procedure and patients receiving placebo in similar arrangements. Besides the impact on the volume of intraoperative bleeding and operative duration and the incidence of postoperative blood transfusion and reoperative hemostasis were evaluated.
Inclusion Criteria:Palatoplasty indication in patients with presence of congenital cleft palate (with or without associated cleft lip).
Exclusion Criteria:
Preoperative hemoglobin lower than 10 mg/dl or platelet count less than 100,000/mm3 ;
Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions;
History of bleeding disorders in first-degree relatives;
Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants);
Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula;
Known allergy to tranexamic acid;
History of hematuria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112325208N1
Registration date:2016-01-17, 1394/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Motalleb Salehpoor
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 910 443 5309
Email address
motallebsalehpoor@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative intravenous tranexamic acid on hemorrhage in patients who undergoing cleft palate reconstraction surgery
Public title
The effect tranexamic acid on hemorrhage in cleft palate reconstraction surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Palatoplasty indication in patients with presence of congenital cleft palate (with or without associated cleft lip).
Exclusion Criteria:
Preoperative hemoglobin lower than 10 mg/dl or platelet count less than 100,000/mm3;
Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions;
History of bleeding disorders in first-degree relatives;
Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants);
Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula;
Known allergy to tranexamic acid;
History of hematuria.
Age
From 1 year old to 12 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients will be randomized into the study and randomly using randomized block into a control group or to be investigation group(Double-blind randomized study).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Integrating the campus of the University of Medical Sciences
City
Zahedan
Postal code
۹۸۱۶۷۴۳۴۶۳
Approval date
2015-11-08, 1394/08/17
Ethics committee reference number
IR.ZAUMS.REC.13940300
Health conditions studied
1
Description of health condition studied
cleft palate with or without cleft lip
ICD-10 code
Q35,Q37
ICD-10 code description
Cleft palate, Cleft palate with cleft lip
Primary outcomes
1
Description
intraoperative bleeding
Timepoint
during surgery
Method of measurement
Intraoperative bleeding volume defined as the sum of the volume blood in the suction during the procedure and the volume of blood retained in the used gauze
2
Description
operative duration
Timepoint
since anesthesia induction until patient exited from operation room
Method of measurement
Data collection form
Secondary outcomes
1
Description
Hemoglobin(Hb)
Timepoint
6 hour after procedure
Method of measurement
Data collection form
2
Description
bleeding requiring reoperative homeostasis
Timepoint
post operation
Method of measurement
Data collection form
Intervention groups
1
Description
Control: patients befor incision received placebo(normal saline) acid at a dose of 10 mg/kg bolus followed by continuous infusion of 1 mg/kg/h until the end of the procedur.
Category
Placebo
2
Description
Intervention: patients befor incision received tranexamic acid(Caspian Tamin Pharmaceutical Co.) at a dose of 10 mg/kg bolus followed by continuous infusion of 1 mg/kg/h until the end of the procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamolanbia Hospital
Full name of responsible person
Gholam Ali Dashti Khavidaki
Street address
ENT clinic of Khatamolanbia Hospital
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Zahedan University of Medical Sciences
Full name of responsible person
Gholam Ali Dashti Khavidaki
Street address
ENT clinic of Khatamolanbia Hospital
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Gholam Ali Dashti Khavidaki
Position
Board in Otorhinolaryngology
Other areas of specialty/work
Street address
ENT clinic of Khatamolanbia Hospital
City
Zahedan
Postal code
Phone
+98 543218848
Fax
Email
drdashti50@yahoo.com
Web page address
www.dr-dashti.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Gholam Ali Dashti Khavidaki
Position
Board in Otorhinolaryngology
Other areas of specialty/work
Street address
ENT clinic of Khatamolanbia Hospital
City
Zahedan
Postal code
Phone
+98 543218848
Fax
Email
drdashti50@yahoo.com
Web page address
www.dr-dashti.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
motalleb salehpoor
Position
Medical student
Other areas of specialty/work
Street address
Integrating the campus of the University of Medical Sciences, Pardis Dormitory
City
Zahedan
Postal code
Phone
00
Fax
Email
salehpoor5@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)