Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

Status Terminated

Clinical Trial Summary

Some patients undergoing cardiac surgery develop excessive postoperative bleeding. Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired platelet disorders. In this study the investigators will investigate wether desmopressin reduces postoperative microvascular bleeding. The investigators will investigate wether desmopressin reduces platelet activation as measured by plasma concentration of neutrophil activating peptid 2 and by flow cytometry. The primary endpoint of the study will, however, be total postoperative bleeding and need for transfusions of blood components after surgery. The need for transfusions will be registered during the whole hospital stay. Patient with excessive postoperative bleeding (more than 250 ml for one hour, or more than 150ml for two hours during the first four hours) will be randomized into two groups and given either desmopressin or placebo (0,9% sodium chloride) as an intravenous infusion. Blood samples for plasma concentration measurements will be drawn before infusion of desmopressin/placebo, immediately after the infusion and 20 hours postoperatively. Postoperative bleeding will be registered for 16 hours. The need for any transfusions of blood products will be registered for the whole hospital stay.

Clinical Trial Description

n/a

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

Clinical Trial Details

NCT number	NCT00885924
Study type	Interventional
Source	St. Olavs Hospital
Contact
Status	Terminated
Phase	Phase 4
Start date	March 2009
Completion date	February 2012

View Details

See also
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	`NCT02569606` - Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Completed	`NCT02554006` - Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings	N/A
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	`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	`NCT01210417` - Trauma Heart to Arm Time	N/A
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