Desmopressin in Acquired von Willebrand Syndrome caused by Aortic Valve Stenosis - Desmopressin in Acquired von Willebrand Syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004559-36-AT

Enrollment

Registered

2006-02-16

Start date

2006-03-23

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired type 2A von Willebrand syndrome is common in patients with severe aortic valve stenosis (AS). It originates from the mechanical obstruction of blood flow and the consecutive proteolysis of von vWF (von Willebrand factor) as it passes through the stenotic valve. Type 2A von Willebrand syndrome (vWS) is characterized by the loss of the largest multimers of vWF, which are the most effective in platelet-mediated hemostasis under conditions of high shear stress.

Interventions

Trade Name: Octostim Product Name: Octostim Product Code: 436394 Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Signed informed consent form before trial-related activities ? Patients undergoing elective bioprosthetic aortic valve replacement ? Left ventricular ejection fraction > 40% ? Patients aged ? 18 and ? 90 years ? Prolonged closure time PFA-100 (ADP)> 170 (s). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? Participation in another clinical trial ? Incompetence to give consent (language and comprehension) ? Active endocarditis ? Association with coronary artery disease ? Multivalvular disease ? Antiplatelet treatment that could not be stopped 7 days before surgery ? Pregnancy or child-bearing potential ? BMI > 40 kg/m2 ? Serum creatinine > 1.5 mg/dL ? Known hypersensitivity towards DDAVP

Design outcomes

Primary

Measure	Time frame
Main Objective: We are interested whether DDAVP favorably affects ?vWF related parameters ( see 3.6. primary efficiacy endpoints ) and their perioperative recovery ?postoperative blood loss (collected over 48 hrs into chest tube drains ) ?perioperative blood component use in patients with AS related acquired vWS (pre-trial screening ) ;Secondary Objective: ?correlation of potential postoperative aortic valve restenosis and abnormalities of vWF related parameters. ;Primary end point(s): ? von Willebrand factor antigen (vWF:Ag) ?Ristocetincofactor/ von Willebrand factor antigen ratio ?Closure time (PFA-100) Collagen Adenosin 5-diphosphate closure time, (CAPD-CT) Collagen Epinephrine closure time (CEPI-CT) (s) ?vWF collagen-binding activity (vWF:CBA) ?von Willebrand factor ristocetin cofactor ?percentage of highest molecular-weight multimers	—

Measure

Time frame

Main Objective: We are interested whether DDAVP favorably affects ?vWF related parameters ( see 3.6. primary efficiacy endpoints ) and their perioperative recovery ?postoperative blood loss (collected over 48 hrs into chest tube drains ) ?perioperative blood component use in patients with AS related acquired vWS (pre-trial screening ) ;Secondary Objective: ?correlation of potential postoperative aortic valve restenosis and abnormalities of vWF related parameters. ;Primary end point(s): ? von Willebrand factor antigen (vWF:Ag) ?Ristocetincofactor/ von Willebrand factor antigen ratio ?Closure time (PFA-100) Collagen Adenosin 5-diphosphate closure time, (CAPD-CT) Collagen Epinephrine closure time (CEPI-CT) (s) ?vWF collagen-binding activity (vWF:CBA) ?von Willebrand factor ristocetin cofactor ?percentage of highest molecular-weight multimers

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 20, 2026