Trial record 5 of 20 for:    "pfeiffer syndrome" OR "craniosynostoses" OR "acrocephalosyndactylia"

Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Tara Der, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01094977
First received: March 23, 2010
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.


Condition Intervention Phase
Craniosynostoses
Drug: Tranexamic Acid
Drug: Saline Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid Undergoing Craniosynostosis Reconstruction: A Randomized Placebo-Controlled Double Blind Study of Low and High Dose Therapy

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Blood Loss [ Time Frame: Prior and Post Surgery ] [ Designated as safety issue: No ]
    Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.


Secondary Outcome Measures:
  • Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples [ Time Frame: Sample will be drawn immediately after induction and prior to administration of study drug ] [ Designated as safety issue: No ]
    PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery

  • Thromboelastography (TEG)Sample [ Time Frame: Baseline, immediately after bolus dose of TXA is infused ] [ Designated as safety issue: No ]
    TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis)


Estimated Enrollment: 90
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose
TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure
Drug: Tranexamic Acid
10 mg/kg bolus with a 5 mg/kg/h infusion
Experimental: High Dose
TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure
Drug: Tranexamic Acid
100 mg/kg bolus with a 10 mg/kg/h infusion
Placebo Comparator: Placebo
Normal saline 10 ml before skin incision and infusion according to weight until skin closure
Drug: Saline Placebo

Detailed Description:

Blood loss during pediatric craniosynostosis surgery can be significant and this may be exacerbated by a dilutional coagulopathy. Multimodal blood conservation strategies may limit allogeneic transfusions, although RCTs are few and limited. It is essential to investigate these techniques to determine their potential to reduce allogeneic blood transfusions and their associated cost and morbidity.

Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. The result is inhibition of fibrinolysis and clot degradation.

Recent studies in adults undergoing cardiac surgery demonstrated that people with different genotypes for the plasminogen activator inhibitor-1 (PAI-1) gene may have varying degrees of bleeding. PAI-1 inhibits the transformation of plasminogen to plasmin thereby decreasing plasmin-induced fibrinolysis. Thus, PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery.

  Eligibility

Ages Eligible for Study:   2 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction

Exclusion Criteria:

  • Known bleeding disorder as this may increase the risk of bleeding
  • Current antifibrinolytic therapy as these patients may bleed less
  • Patient or family history of thromboembolic disease as there may be potential risk of thrombosis
  • Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding
  • Known allergy to TXA
  • History of renal insufficiency as TXA is renally excreted
  • Acquired colour vision defects as one of the first signs of long term TXA toxicity is colour vision disturbance.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094977

Contacts
Contact: Tara Der, MD 416-813-7654 ext 2405 tara.der@sickkids.ca
Contact: Carolyne Pehora, RN 416-813-7654 ext 2406 carolyne.pehora@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Principal Investigator: Tara Der, MD         
Sub-Investigator: Christian Zaarour, MD         
Sub-Investigator: Mark Crawford, MD         
Sub-Investigator: Guy Petroz, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Tara Der, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Tara Der, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01094977     History of Changes
Other Study ID Numbers: 1000013836
Study First Received: March 23, 2010
Last Updated: August 27, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Blood Loss and Transfusion
Craniosynostoses
Tranexamic Acid
Children

Additional relevant MeSH terms:
Craniosynostoses
Hemorrhage
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Plagiocephaly
Congenital Abnormalities
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014