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Tranexamic Acid for Craniofacial Surgery

Primary Purpose

Craniosynostosis, Bleeding

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Tranexamic acid

saline

About this trial

This is an interventional treatment trial for Craniosynostosis focused on measuring antifibrinolytic, tranexamic acid

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The inclusion of the patients will depend on the following criteria:

All pediatric patients scheduled for primary or secondary repair of craniosynostosis with a frontal orbital advancement, or cranial vault reconstruction.
Patients will be between the ages of 6 months and 18 years old.
They will be > than 5 kg.
All subjects being evaluated in the Craniofacial Clinic for primary or secondary repair of craniosynostosis will potentially be included in the study. Prior to inclusion in the study potential participants will be screened by history and laboratory data. The laboratory data will include a complete blood count, PT, PTT, type and cross, factor V leiden, anticardiolipin antibody, and lupus anticoagulant. The history will be obtained from the parents or current care takers. The medical records may be reviewed if there is a need for clarification.

Exclusion Criteria:

Patients that will be excluded from the study include the following:

Familial or personal coagulopathy risk-factor V leiden, anticardiolipin antibody, and lupus anticoagulant
Abnormal PT, PTT, Platelet count. or closing time. All patients presenting for craniofacial surgery have preoperative blood work performed which includes a type and screen, HCT, PLT, PT, PTT, and closing time. Patients who have abnormalities detected in their coagulation profile proceed on to a complete hematologic evaluation that includes an evaluation for Von Willebrand's Disease.
History of thrombotic episodes in the patient
Renal failure or hepatic failure.
Infants less than 5 kg
Age < 6 months or > 18 years old

Sites / Locations

The Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic acid

Placebo

Arm Description

Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous

Saline was administered intravenously

Outcomes

Primary Outcome Measures

Total Volume (ml/kg) of Allogeneic Blood Exposure.

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.

Number of Patients That Remained Transfusion Free

Secondary Outcome Measures

Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).

Platelets

Full Information

NCT ID

NCT00722436

First Posted

July 23, 2008

Last Updated

February 10, 2017

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT00722436

Brief Title

Tranexamic Acid for Craniofacial Surgery

Official Title

Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

Study dose changed based on recent publications

Study Start Date

July 2008 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries.

Detailed Description

Surgical procedures for the correction of craniofacial deformities result in unavoidable and significant blood loss in small children and infants. Patients may experience blood losses that exceed one to two blood volumes. In an effort to reduce our transfusion requirements, we have introduced tranexamic acid into our practice. However, the benefit of tranexamic acid in pediatric craniofacial surgery has not yet been reported. We hypothesize that the intraoperative use of tranexamic acid in pediatric patients presenting for craniofacial reconstructions will reduce blood loss and allogeneic transfusion requirements. This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries. An initial dose of 100 mg/kg tranexamic acid (Cyclokapron 100mg/ml) or an equal volume of a placebo will be administered over 15 minutes after the induction of anesthesia and before the skin incision. A maintenance infusion of 10 mg/kg/hr of tranexamic acid or equal volume of a placebo will be started upon completion of the initial dose and will be continued until skin closure. The primary outcome will include the reduction in the total volume of allogeneic erythrocytes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Craniosynostosis, Bleeding

Keywords

antifibrinolytic, tranexamic acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic acid

Arm Type

Experimental

Arm Description

Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Saline was administered intravenously

Intervention Type

Drug

Intervention Name(s)

Tranexamic acid

Intervention Description

100 mg/kg load, then 10 mg/kg/hr

Intervention Type

Drug

Intervention Name(s)

saline

Intervention Description

Placebo

Primary Outcome Measure Information:

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)

Title

Number of Patients That Remained Transfusion Free

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).

Time Frame

(baseline, after osteotomies, and immediately after procedure)

Title

Platelets

Time Frame

baseline, after osteotomies, immediately after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The inclusion of the patients will depend on the following criteria: All pediatric patients scheduled for primary or secondary repair of craniosynostosis with a frontal orbital advancement, or cranial vault reconstruction. Patients will be between the ages of 6 months and 18 years old. They will be > than 5 kg. All subjects being evaluated in the Craniofacial Clinic for primary or secondary repair of craniosynostosis will potentially be included in the study. Prior to inclusion in the study potential participants will be screened by history and laboratory data. The laboratory data will include a complete blood count, PT, PTT, type and cross, factor V leiden, anticardiolipin antibody, and lupus anticoagulant. The history will be obtained from the parents or current care takers. The medical records may be reviewed if there is a need for clarification. Exclusion Criteria: Patients that will be excluded from the study include the following: Familial or personal coagulopathy risk-factor V leiden, anticardiolipin antibody, and lupus anticoagulant Abnormal PT, PTT, Platelet count. or closing time. All patients presenting for craniofacial surgery have preoperative blood work performed which includes a type and screen, HCT, PLT, PT, PTT, and closing time. Patients who have abnormalities detected in their coagulation profile proceed on to a complete hematologic evaluation that includes an evaluation for Von Willebrand's Disease. History of thrombotic episodes in the patient Renal failure or hepatic failure. Infants less than 5 kg Age < 6 months or > 18 years old

Facility Information:

Facility Name

The Children's Hospital of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We stopped the study early because emerging data came out that demonstrated benefit with significantly lower doses than our study. We were compelled to stop enrolling.

Citations:

PubMed Identifier

11429344

Citation

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. doi: 10.1097/00000539-200107000-00018.

Results Reference

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PubMed Identifier

15791100

Citation

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. doi: 10.1097/00000542-200504000-00006.

Results Reference

background

PubMed Identifier

11279735

Citation

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. doi: 10.1002/14651858.CD001886.

Results Reference

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Tranexamic Acid for Craniofacial Surgery

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