Idiopathic ScoliosisNCT02084342
Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
A study testing tranexamic acid and sodium chloride injection, normal saline and desmopressin acetate injection in people with Idiopathic Scoliosis, run by Liu Weifeng.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- tranexamic acid and sodium chloride injection, normal saline and desmopressin acetate injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- idiopathic scoliosis patients undergoing posterior scoliosis correction surgery
- American society of anesthesiologists(ASA) classification:Ⅰ-Ⅱ
- patients who agreed to participate in this study and has signed the informed consent
Who cannot join
- 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
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- administering with anticoagulants or nonsteroidal anti-inflammatory drug(NSAID)
- hepatic or renal disease or disfunction
- blood transfusion in recent one month
About this study
Official title: Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
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.
Read the detailed 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.
- Conditions
- Idiopathic Scoliosis
- Being tested
- tranexamic acid and sodium chloride injection, normal saline, desmopressin acetate injection
- Keywords
- desmopressin, tranexamic acid, blood loss, transfusion need, posterior scoliosis orthopedics
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acid and sodium chloride injectionDrug
Also called TXA
10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.
normal salineDrug
Also called NS
100ml, IV for 30min,before incision.
desmopressin acetate injectionDrug
Also called DDAVP
0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.
| Study group | Role | What they receive |
|---|---|---|
| Group TN | Placebo comparator | Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min, before incision.Then at 1mg/kg/h, IV pump, until the surgery is over.
Normal saline (NS) 100ml IV for 20min, before incision. Receives: Drug: tranexamic acid and sodium chloride injection; Drug: normal saline |
| Group TD | Experimental | Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min,before incision.Then at 1mg/kg/h,IV pump,until the surgery is over.
Desmopressin acetate injection at 0.3μg/kg dissolved in 100ml NS, IV for 20min, before incision. Receives: Drug: tranexamic acid and sodium chloride injection; Drug: desmopressin acetate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during and 3 days after the surgery
Secondary outcomes (1)
blood transfusion
The blood transfusion includes all the product needed during and in 3 days after the surgery.
Measured: during and 3 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Weifeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Weifeng, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Wenqi Huang, Ph.D, M.D., Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084342
- Sponsor's protocol ID
- TDS-SYSU-2013
- Status last verified
- Mar 2014
- First submitted
- 15 Dec 2013
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
- ClinicalTrials.gov ID
- NCT02084342
- Acronym / sponsor ID
- TDS-SYSU-2013
- Conditions
- Idiopathic Scoliosis
- Keywords
- desmopressin, tranexamic acid, blood loss, transfusion need, posterior scoliosis orthopedics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liu WeifengUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TN | Placebo comparator | Drug: tranexamic acid and sodium chloride injection, Drug: normal salineTranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min, before incision.Then at 1mg/kg/h, IV pump, until the surgery is over. Normal saline (NS) 100ml IV for 20min, before incision. |
| Group TD | Experimental | Drug: tranexamic acid and sodium chloride injection, Drug: desmopressin acetate injectionTranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min,before incision.Then at 1mg/kg/h,IV pump,until the surgery is over. Desmopressin acetate injection at 0.3μg/kg dissolved in 100ml NS, IV for 20min, before incision. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- idiopathic scoliosis patients undergoing posterior scoliosis correction surgery
- American society of anesthesiologists(ASA) classification:Ⅰ-Ⅱ
- patients who agreed to participate in this study and has signed the informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tranexamic acid and sodium chloride injectionAlso: TXA10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over. | Drug | Group TD, Group TN |
| normal salineAlso: NS100ml, IV for 30min,before incision. | Drug | Group TN |
| desmopressin acetate injectionAlso: DDAVP0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision. | Drug | Group TD |
Primary outcome
blood loss
Time frame: during and 3 days after the surgery
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.
1 secondary outcome
blood transfusion
Time frame: during and 3 days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenqi Huang, Ph.D, M.D. study chair
First Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A study testing tranexamic acid and sodium chloride injection, normal saline and desmopressin acetate injection in people with Idiopathic Scoliosis, run by Liu Weifeng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: during and 3 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.