Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery

NCT00885924 | Terminated Phase 4

• 1 other identifier: 4.2008.947
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemorrhage; Postoperative Blood Loss

Keywords

postoperative Hemorrhage; Hemorrhage; Vasopressin; Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

• Transfusion of blood components

  During postoperative stay

Secondary Outcomes (3)

• Postoperative hemorrhage

  First 16 hours postoperatively

• Platelet activation

  20 hours postoperatively

• Activation of coagulation

  20 hours postoperatively

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Desmopressin 0.3 microgram/kg

Drug: Desmopressin

Placebo

PLACEBO COMPARATOR

NaCl 0.9%

Drug: Placebo

Interventions

Desmopressin DRUG

Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.

Also known as: Octostim, Ferring ATC-nr.:H01B A02

Active treatment

Placebo DRUG

NaCl 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 18 years of age scheduled for cardiac surgery
• Excessive postoperative bleeding, more than 250 ml for one hour, or more than 150ml for two hours during the first four hours

You may not qualify if:

• Patients younger than 18 years of age
• Patients with a medical condition known to influence the hemostatic system
• Patients treated with clopidogrel or systemic steroids during the last week before surgery
• Patients with INR above 1.5
• Patients who are not able to give written informed concent
• Unstable patients who need other transfusion limits than in this study

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

StOlavs Hopital

Trondheim, Trondheim, 7018, Norway

Location

MeSH Terms

Conditions

Hemorrhage; Postoperative Hemorrhage; Diabetes Insipidus; Blood Loss, Surgical

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Guri Greiff, MD

  StOalvs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 22, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

NO (1)