Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery

Idiopathic Scoliosis Clinical Trial

Official title:

Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02084342
• Other study ID #: TDS-SYSU-2013
• Status: Active, not recruiting
• Phase: N/A
• First received: December 15, 2013
• Last updated: March 10, 2014
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. TXA acts mainly by inhibit the plasminogen activator.

Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type plasminogen activator (t-PA), which may cripple its hemostatic effect.

The investigators supposed that if the investigators combine TXA with DDAVP in scoliosis correction surgery, the blood loss and the transfusion need would be reduced significantly.

Description:

Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. TXA acts mainly by inhibit the plasminogen activator. Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type plasminogen activator (t-PA), which may cripple its hemostatic effect.

The investigators designed a a randomized double-blind clinical combining TXA with DDAVP in scoliosis correction surgery to observe if the blood loss and the transfusion need would be reduced or not.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• idiopathic scoliosis patients undergoing posterior scoliosis correction surgery

• American society of anesthesiologists(ASA) classification:?-?

• patients who agreed to participate in this study and has signed the informed consent

Exclusion Criteria:

• blood disease,such as anaemia, idiopathic thrombocytopenic purpura(ITP)

• history of bleeding or ecchymosis

• disorders of laboratory examination on platelets(PLT),prothrombin time(PT),activated partial thromboplastin Time(aPTT),Fibrinogen,D-dimers

• hypertension

• cardiac disease,such as unstable angina, myocardial infarction in recent sis months, cardiac disfunction, congenital heart disease, pulmonary heart disease

• cerebral ischemia

• administering with anticoagulants or nonsteroidal anti-inflammatory drug(NSAID)

• hepatic or renal disease or disfunction

• blood transfusion in recent one month

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Idiopathic Scoliosis
• Scoliosis

Intervention

Drug:
• tranexamic acid and sodium chloride injection
10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.
• normal saline
100ml, IV for 30min,before incision.
• desmopressin acetate injection
0.3µg/kg dissolved in 100ml NS,IV for 30min,before incision.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liu Weifeng

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative complications		up to 24 weeks after the surgery	Yes
Primary	blood loss	The blood loss include the volume of blood in suction bottles, the weight of sponges and seroma volume of drainage 3 days after surgery. All fluids added to the surgical field intraoperatively were carefully quantified and deducted from the measured blood loss.	during and 3 days after the surgery	Yes
Secondary	blood transfusion	The blood transfusion includes all the product needed during and in 3 days after the surgery.	during and 3 days after the surgery	No