Tranexamic Acid for Craniofacial Surgery

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Conditions	Craniosynostosis; Bleeding
Interventions	Drug: Tranexamic acid; Drug: saline
Enrollment	20

Participant Flow

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Recruitment Details
Pre-assignment Details

Arm/Group Title	Tranexamic Acid	Placebo
Arm/Group Description	Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr Patients are randomized to TXA or saline. This group is the TXA group.	Saline saline: Placebo
Period Title: Overall Study
Started	9	11
Completed	9	11
Not Completed	0	0

Baseline Characteristics

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Arm/Group Title		Tranexamic Acid	Placebo	Total
Arm/Group Description		Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr Patients are randomized to TXA or saline. This group is the TXA group.	Saline saline: Placebo	Total of all reporting groups
Overall Number of Baseline Participants		9	11	20
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	11 participants	20 participants
	<=18 years	9 100.0%	11 100.0%	20 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	11 participants	20 participants
	Female	3 33.3%	5 45.5%	8 40.0%
	Male	6 66.7%	6 54.5%	12 60.0%

Outcome Measures

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1. Primary Outcome

Title	Total Volume (ml/kg) of Allogeneic Blood Exposure.
Description	This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.
Time Frame	intraoperative and postoperative (24 hr)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tranexamic Acid	Placebo
Arm/Group Description:	Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr Patients are randomized to TXA or saline. This group is the TXA group.	Saline saline: Placebo
Overall Number of Participants Analyzed	9	11
Mean (Standard Deviation); Unit of Measure: ml/kg
	16.1 (13.9)	17.1 (10.4)

2. Primary Outcome

Title	Number of Patients That Remained Transfusion Free
Description	[Not Specified]
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tranexamic Acid	Placebo
Arm/Group Description:	Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr Patients are randomized to TXA or saline. This group is the TXA group.	Saline saline: Placebo
Overall Number of Participants Analyzed	9	11
Measure Type: Number; Unit of Measure: participants
	2	0

3. Secondary Outcome

Title	Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
Description	[Not Specified]
Time Frame	(baseline, after osteotomies, and immediately after procedure)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tranexamic Acid	Placebo
Arm/Group Description:	Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr Patients are randomized to TXA or saline. This group is the TXA group.	Saline saline: Placebo
Overall Number of Participants Analyzed	9	11
Mean (Standard Deviation); Unit of Measure: seconds
PT -baseline	15.1 (0.84)	13.8 (0.74)
PT-after osteotomies	18.5 (3.93)	16.1 (1.94)
PT-immediately after surgery	17.7 (1.18)	17 (1.74)
PTT -baseline	34.6 (2.92)	32.9 (2.67)
PTT-after osteotomies	37.2 (9.75)	34.6 (3.62)
PTT-immediately after surgery	33.3 (3.5)	34.8 (3.9)

4. Secondary Outcome

Title	Platelets
Description	[Not Specified]
Time Frame	baseline, after osteotomies, immediately after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tranexamic Acid	Placebo
Arm/Group Description:	Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr Patients are randomized to TXA or saline. This group is the TXA group.	Saline saline: Placebo
Overall Number of Participants Analyzed	9	11
Mean (Standard Deviation); Unit of Measure: 10^9 platelets/L
platelets-baseline	301 (109)	364 (125)
platelets-after osteotomies	253 (101)	300 (107)
platelets-immediately after surgery	223 (89)	231 (99)

Adverse Events

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Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Tranexamic Acid	Placebo
Arm/Group Description	Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr Patients are randomized to TXA or saline. This group is the TXA group.	Saline saline: Placebo
All-Cause Mortality
	Tranexamic Acid	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Tranexamic Acid	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/9 (0.00%)	0/11 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Tranexamic Acid	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/9 (0.00%)	0/11 (0.00%)

Limitations and Caveats

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Study terminated because two studies published during the trial demonstrated efficacy of tranexamic acid at a lower dose.

More Information

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Name/Title: Franklyn Cladis

Organization: The Childrens Hospital of Pittsburgh of UPMC

Phone: 412-692-5260

EMail: cladfp@upmc.edu

Publications:

Neilipovitz DT, Murto K, Hall L, Barrowman NJ, Splinter WM. A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7.

Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32.

Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. Review. Update in: Cochrane Database Syst Rev. 2007;(4):CD001886.

Responsible Party:	Franklyn Cladis, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00722436 History of Changes
Other Study ID Numbers:	PRO07120134
First Submitted:	July 23, 2008
First Posted:	July 25, 2008
Results First Submitted:	September 16, 2016
Results First Posted:	February 15, 2017
Last Update Posted:	February 15, 2017