Hemorrhage Clinical Trial
Official title:
Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation
This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.
Status | Recruiting |
Enrollment | 270 |
Est. completion date | March 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 28 Days |
Eligibility |
Inclusion Criteria: - Newborns < day 28 of life - Necessity for intensive care treatment - Necessity for parenteral drug or fluid application for at least five days - Informed consent of parents Exclusion Criteria: - Body weight < 500g - Mechanical ventilation directly after birth - Major malformations - Absolute indication for heparin - Inborn hemorrhagic disease (e.g. hemophilia, von Willebrand disease) - Cerebral bleeding or other major bleeding - Platelet count < 50,000/µl |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine | Greifswald |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of neonates requiring mechanical ventilation | |||
Secondary | duration of dependency on mechanical ventilation | |||
Secondary | major bleeding | |||
Secondary | heparin induced thrombocytopenia | |||
Secondary | anti PF4/heparin antibodies |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02815670 -
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
|
Phase 3 | |
Completed |
NCT04588350 -
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
|
N/A | |
Recruiting |
NCT02972385 -
Pharmacogenomics of Warfarin in Hispanics and Latinos
|
||
Completed |
NCT02554006 -
Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings
|
N/A | |
Completed |
NCT02569606 -
Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
|
||
Recruiting |
NCT02446730 -
Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome
|
Phase 4 | |
Completed |
NCT01935427 -
Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume
|
N/A | |
Completed |
NCT01955720 -
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
|
Phase 1 | |
Recruiting |
NCT01709786 -
Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage
|
N/A | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A | |
Completed |
NCT01191554 -
Dose-ranging Study of Tranexamic Acid in Valve Surgery
|
N/A | |
Completed |
NCT01136590 -
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
|
Phase 4 | |
Completed |
NCT01085006 -
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
|
Phase 1/Phase 2 | |
Completed |
NCT00700141 -
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
|
N/A | |
Completed |
NCT00375466 -
Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.
|
N/A | |
Completed |
NCT00479362 -
Anticoagulant Therapy During Pacemaker Implantation
|
Phase 4 | |
Completed |
NCT00147420 -
RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
|
N/A | |
Recruiting |
NCT05945680 -
Tranexamic Acid in Breast Esthetic Surgery.
|
Phase 4 | |
Completed |
NCT03273322 -
Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure
|
Phase 2/Phase 3 | |
Withdrawn |
NCT05672407 -
The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
|
Phase 4 |